HK1179891A - Use of a fatty acid composition comprising at least one of epa and dha or any combinations thereof - Google Patents

Description

Use of a fatty acid composition comprising at least one of EPA and DHA or any combination thereof

The application is a divisional application with application number 200480040211.2, application date 2004-12/17, entitled "use of fatty acid composition containing at least one of EPA and DHA, or any combination thereof".

Technical Field

The present invention includes a number of aspects. According to a first aspect of the present invention, the use of a novel medical product for controlling weight loss, preventing weight gain and treating and/or preventing obesity or overweight is disclosed. According to a second aspect of the invention, a method of treating and/or preventing obesity, an overweight condition or controlling weight loss is disclosed. According to a third aspect of the present invention, the use of a food product or dietary supplement for controlling and assisting weight loss and/or preventing weight gain in a human or animal is disclosed. Furthermore, according to a fourth aspect of the present invention, a dietary product for the non-pharmaceutical treatment of obesity, an overweight condition and/or for aiding and controlling weight loss and/or for preventing weight gain is disclosed. Furthermore, according to a fifth aspect of the present invention, the use of a dietetic food or food supplement for controlling and assisting weight loss and/or for preventing weight gain is disclosed. Finally, according to a sixth aspect of the present invention, a method of supplementing a dietetic food is disclosed. The above aspects are based on at least one of the following features: a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof, or a step of adding a fatty acid composition comprising at least one of EPA and PHA, or any combinations thereof, to a supplement product.

Background

More and more individuals become overweight or obese, which is now considered the most common nutritional disorder in industrialized countries. Body mass indices above 25 or 30 can be identified as overweight conditions and obesity. The normal range is 18-25. In the united states 34% of the population is overweight and the other 27% is obese. This means that over 60% of the entire population in the united states is defined as having weight problems that may cause serious health problems, such as hypertension and elevated blood lipids, which are risk factors for cardiovascular disease.

Overweight conditions and obesity can be caused by imbalances in energy intake and energy expenditure. People tend to eat too much and move too little in industrialized countries. However, the likelihood of becoming obese under these conditions is not the same for everyone, as evidenced by the fact that slim individuals are still present under the same conditions as those of overweight. Moreover, the discovery that nutritional factors can control gene expression has opened the possibility of developing new alternative therapies for the treatment of obesity. The main challenge in therapeutic regimens aimed at treating obesity and reducing body fat deposition is that these regimens are directly opposite to effective and diverse mechanisms involving the storage of metabolic energy and the survival of the body in the absence of nutrients.

Once stored in adipose tissue, metabolic energy is released only under conditions of negative energy balance of large food intake, i.e. during fasting and/or physical exercise. Importantly, the loss of tissue energy under these conditions results from two cases: increased fatty acid secretion in adipose tissue cells and catabolism of tissue lipids, increased catabolism during fasting (Wang T et al, Obesity Research 11:880-887, 2003).

Fat consists of fatty acids, and fat is the most caloric dense nutrient. A high fat diet is associated with excessive weight gain, but not all fats are the same. In the gastrointestinal tract, fat is broken down into fatty acids by lipases and absorbed into intestinal cells. In intestinal cells, the lymphatic system and the liver, fat complexes are produced to transport fatty acids. In the circulation, these fatty acids are released by lipases which enter the cell or integrate into the cell membrane. Most fatty acids are used for energy production, but some fatty acids, especially polyunsaturated fatty acids, also have other functions, including interaction with cellular proteins, which in turn enter the nucleus and close and open genes. These genes are known to encode certain proteins that are important in controlling the production of energy from glucose and fat.

Fatty acids differ in their three-dimensional structure, which is determined by the length of the molecular chain and the number of double bonds present. The most common dietary fats are medium to long chain fatty acids. Saturated fatty acids have no double bonds and form straight chain molecules. If a double bond is present, an angle of 120 degrees is formed. Thus, polyunsaturated fatty acids (PUFAs) have a completely different spatial structure compared to saturated fatty acids. The difference in three-dimensional structure between fatty acids means that PUFAs can act as signaling agents for cells, turning gene transcription off or on, whereas saturated fatty acids cannot be recognized and have no effect. In laboratory calorimeters, all fats, whether saturated or unsaturated, produce 9 calories/gram of energy, but in the dietary portion, PUFAs have a completely different net effect on metabolic energy production and weight gain than saturated fatty acids. Thus, saturated fatty acids are the main source of energy in the human body, while PUFAs perform different functions. The PUFA is mainly derived from seeds, nuts and fish oil. They may have a first double bond, located at the carbon atom 3, 6 or 9 away from the chain end. Thus, they are referred to as either omega-3, omega-6, and omega-9 fatty acids or as n-3, n-6, and n-9 fatty acids. Humans cannot synthesize fatty acids with double bonds at positions 3 or 6, which make them essential dietary components. In some cases, both types of PUFAs may have the same effect. One example is that PUFAs have an inhibitory effect on lipid synthesis in the liver, while at the same time having a positive regulatory effect on fatty acid oxidation in the liver and skeletal muscle. PUFAs have been shown to reduce hepatic gene transcription encoding glycolytic and lipogenic enzymes. The effect of PUFAs on gene expression in the liver and muscle thus leads to increased metabolism and reduced fat storage, thereby helping to prevent weight gain. Energy conversion occurs primarily within the mitochondria within the cell. Mitochondria preferentially oxidize medium and short chain fatty acids. The released energy is converted to ATP, which can be used in a number of energy-dependent processes. However, mitochondrial energy conversion is not 100% efficient and part of the metabolic energy is released as heat. The efficiency of mitochondrial energy conversion is regulated by mitochondrial uncoupling proteins. In addition, PUFAs also affect another site of metabolic energy conversion, peroxisomes, which are also located within the cell membrane. The main role of mitochondria is to produce energy-rich ATP, while peroxisomes are more active in heat generation, while they can shorten polyunsaturated long-chain fatty acids before they are further oxidized in mitochondria. The net effect is an increase in heat production, rather than an increase in fat deposition. PUFAs are peroxisome proliferators that increase the number and activity of peroxisomes.

In addition, fasting is a major physiological state that inhibits Obesity, during which several mechanisms reduce adipocyte energy levels, such as mitochondrial uncoupling protein 2 upregulation (see Millet L et al, J.Clin. invest.100: 2665-. Furthermore, it has been found that the reduction of abdominal fat by the use of dietary omega-3 PUFAs in mice is associated with an increased expression level of uncoupling proteins 2 and 3 in adipose tissue (Oudart H. et al, int.J.Obesity and Metab.Disord.24 Supp 1: S130,2000; Hun C.S. et al, biochem. Biophys. Res. Commun.259:85-90, 1999). In addition, it has been found that replacement of 6 g/day of visible fat with fish oil in healthy adults reduces fat mass and increases basal lipid oxidation (Couet C, Delarue J, Ritz P, Antoine J-M and Lamisse F,1997, International Journal of Obesity 21: 637-643), but at the same time fish oil does not have any significant effect on weight loss. Finally, US 2003203004 a1 describes a composition containing short and long chain fatty acids, which can be used for weight control.

Summary of The Invention

According to the present invention, numerous aspects are set out in the appended claims. These aspects are:

1. a new medical product for controlling weight loss, for preventing weight gain and/or for treating and/or preventing obesity or overweight.

2. A method for the treatment and/or prevention of obesity, an overweight condition or for controlling weight loss and/or preventing weight gain.

3. A food or dietary supplement is used for controlling and assisting weight loss and/or preventing weight gain in humans or animals.

4. A dietetic product is used for the non-pharmaceutical treatment and/or prevention of obesity, an overweight condition and/or for assisting and controlling weight loss and/or for inhibiting weight gain.

5. A dietetic food or dietary supplement is used for controlling and assisting weight loss and/or for preventing weight gain.

6. A method for supplementing dietetic food is provided.

The above aspects are according to at least one of the following features:

a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof.

A step of adding a fatty acid composition to the supplement product, the composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof.

According to a first aspect, the present invention relates to the use of a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof, for the manufacture of a pharmaceutical product for controlling weight loss, treating and/or preventing obesity or an overweight condition and/or preventing weight gain. It was surprisingly found from the studies of the present invention that the fatty acid composition according to the present invention can induce weight loss in mice and prevent weight gain in mice fed a High Fat (HF) diet, which is referred to as HF fattening diet.

In a preferred embodiment, the invention relates to the use of a fatty acid composition comprising (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or a derivative thereof or a combination of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA) and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or a derivative thereof in a weight ratio EPA: DHA of 1: X, wherein X is equal to or greater than 1, for the manufacture of a pharmaceutical product for controlling weight loss, treating and/or preventing obesity or an overweight condition and/or preventing weight gain. Note that here X is an integer or a non-integer.

Furthermore, it was found from the studies of the present invention that the most preferred effect of the present invention in weight loss is achieved by a fatty acid composition rich in DHA. The term "rich" here includes fatty acid compositions comprising more or less mainly DHA (without EPA) or derivatives thereof, as well as fatty acid compositions comprising more DHA than EPA. In addition, the term "content" herein refers to the weight or volume of the fatty acid composition. Furthermore, the fatty acid composition of the present invention may achieve a desired pharmacological and/or therapeutic effect.

In addition, as previously known, mere reduction of food does not effectively reduce the body weight of a human. Suitably, the treatment of the invention is combined with at least one of caloric restriction, (fasting), diet and physical exercise, or a combination thereof, which results in weight loss and or inhibition of weight gain in a human or animal. In order to make animals or humans more sensitive to the action of the fatty acid composition according to the invention, it is preferred to design the dietetic therapy, i.e. to reduce the calories.

Furthermore, this opens up a future market for pharmaceutical, food and/or dietetic products comprising the fatty acid composition of the invention, which composition is not only used for the treatment and/or prevention of obesity or overweight, but also for the control and help of weight loss (a method which helps weight control, weight loss, preferably in combination with a reduction of caloric intake) and for the prevention of weight gain, preferably in the case of obesity or overweight progression.

In a preferred embodiment of the invention, the fatty acid composition comprises EPA, DHA or derivatives thereof, wherein EPA: DHA is from 1:1 to 1: 8. In a more preferred embodiment, the EPA: DHA in the fatty acid composition is from 1:1 to 1: 6. In addition, the invention also comprises the use of a fatty acid composition which is a DHA-product or a DHA-derivative product.

In another embodiment, the fatty acid in the composition of the present invention is in one of an esterified form, an ethyl ester form, a salt form, and a free acid form, or any combination thereof. In a preferred embodiment, the fatty acid composition consists of a combination of EPA and DHA or derivatives thereof in triglyceride form.

In another embodiment, at least one of EPA and DHA is obtained from at least one of plants, microorganisms, and animals, or a combination thereof. Thus, the present invention encompasses, for example, fatty acid compositions comprising microbial oils comprising DHA and at least one of a mixture of DHA-containing oils derived from microbes and EPA-containing oils derived from seafood. Furthermore, the fatty acid composition of the present invention may further comprise at least one of arachidonic acid (ARA), docosapentaenoic acid, heneicosapentaenoic acid, and octadecacataenoic acid or a derivative thereof, or any combination thereof. At least a part of the EPA and/or DHA or derivatives thereof may suitably be produced from a marine oil, preferably fish oil. Also, in another embodiment, the fatty acid composition is produced from a marine oil, such as fish oil.

Furthermore, it should be noted that the fatty acid composition is to be administered to humans or animals, preferably orally, for example in the form of a pill or soft capsule. However, the pharmaceutical product of the present invention may also be produced as a product for administration by other routes in which the active ingredient is efficiently absorbed and utilized, for example, by intravenous, subcutaneous or intramuscular administration.

In a preferred embodiment of the invention, the treatment or intake of the human or animal pharmaceutical product is performed together with a reduction of caloric intake. Reducing caloric intake may also be suitably performed in conjunction with physical exercise. If the pharmaceutical product of the invention is applied to humans or animals in combination with a reduction in caloric intake, weight loss will be more effective. In addition, the above method can also prevent weight gain in overweight or obese humans or animals.

In a preferred embodiment of the invention, the fatty acid composition treatment is used in combination with at least 5% caloric restriction. The fatty acid composition treatment is preferably used in combination with a caloric restriction of 10-15%.

In another preferred embodiment of the invention the fatty acid composition comprising at least one of EPA and DHA and derivatives thereof or any combination thereof is administered at a daily dose of 10-40% of the total amount of lipids in a daily diet for human or animal use. This means that the fatty acid composition according to the invention may replace 10-40% of the total amount of lipids in a daily diet. It is noted that another method for determining the daily dosage of the fatty acid composition is presented above.

In another preferred embodiment of the invention, the fatty acid composition is administered in a daily dose of 1g to 15g of said fatty acid composition comprising DHA or a derivative thereof, or a combination of EPA and DHA. In a more preferred embodiment 2-10g of said fatty acid composition is applied per day, in a most preferred embodiment 2-8g of said fatty acid composition is applied per day. It appears from experiments that the fatty acid composition of the invention appears to be particularly potent at high doses. The pharmaceutical product or composition or formulation of the invention may also contain other substances such as inert excipients, or pharmaceutically acceptable adjuvants, carriers, preservatives and the like, all of which are well known to those skilled in the art. The fatty acid composition of the present invention may also be administered in liquid form. In addition, the pharmaceutical product may be applied to animals, such as pets or horses.

According to a second aspect of the invention, the invention relates to a method for the treatment and/or prevention of obesity and overweight, or for the control of body weight loss and/or prevention of body weight gain, in which method an effective amount of a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or combinations thereof, is applied to a human or animal. Herein, "effective amount" also includes therapeutically or pharmaceutically active amounts of the fatty acid composition. Such expression refers to the dosage of the fatty acid composition that produces the desired pharmacological and/or therapeutic effect. As mentioned above, the fatty acid composition of the present invention may achieve a desired pharmacological and/or therapeutic effect.

In a preferred embodiment of the method, the fatty acid composition comprises DHA, a derivative thereof, or a combination of EPA and DHA, wherein the weight ratio EPA: DHA in the fatty acid composition is 1: X, wherein X is equal to or greater than 1. This method yields the same advantages and possibilities as previously described. Thus, the method of the invention is for the treatment and/or prevention of obesity, an overweight condition and/or the control and/or reduction of body weight and prevention of weight gain, preferably for an overweight or obese human or animal, and therefore also includes the above embodiments. In a further embodiment of the method according to the invention, the fatty acid composition is administered in a daily dose corresponding to at least 10% of the total lipid content of a daily diet for humans or animals for the purpose of weight loss.

According to a third aspect, the present invention relates to the use of a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or combinations thereof, in the manufacture of a food product or dietary supplement for controlling and assisting in weight reduction and/or preventing weight gain. It was surprisingly found in the present study that the fatty acid composition of the present invention results in weight loss in mice and prevents weight gain in mice on a High Fat (HF) diet, which is referred to as an HF fattening diet.

In a particular embodiment, the invention relates to the use of a fatty acid composition comprising (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or a derivative thereof or a combination of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA) or a derivative thereof and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or a derivative thereof in the manufacture of a food product or dietary supplement for controlling and helping to reduce body weight and/or to inhibit or slow body weight gain, wherein the weight ratio of EPA: DHA in the fatty acid composition is 1: X, wherein X is equal to or greater than 1. The most preferred effect of the invention in weight loss can also be obtained by applying DHA, derivatives thereof or fatty acid compositions enriched in DHA, i.e. more DHA than EPA. The manufacture and sale of a food product for at least one of reducing weight, controlling and aiding weight loss and/or preventing weight gain is advantageous in that the food product is more readily accepted by a human. They would prefer to purchase the product or supplement in a healthcare shop or supermarket without having to visit a doctor.

In a preferred embodiment of the invention, the fatty acid composition comprises EPA and DHA, or derivatives thereof, wherein EPA: DHA is from 1:1 to 1: 8. In a more preferred embodiment, the EPA to DHA in the fatty acid composition is from about 1:1 to about 1: 6. In another embodiment of the invention, the fatty acid composition is a DHA-product or a DHA-derivative product.

Additionally, in another embodiment, the fatty acids in the composition of the present invention are in at least one of esterified form, ethyl ester form, salt form, and free acid form, or any combination thereof. In a preferred embodiment, the fatty acid composition consists of a combination of EPA and DHA in triglyceride form.

In another embodiment, at least one of EPA and DHA is derived from at least one of plant, microbial, and animal origin. The food product or food supplement thus for example comprises a fatty acid composition comprising a microbial DHA-containing oil and at least one of a mixture of a microbial-derived DHA-containing oil and a marine-derived EPA-containing oil, and the fatty acid composition of the invention may further comprise other fatty acids as described above. At least a part of the EPA and/or DHA may suitably be produced from a marine oil, preferably fish oil.

Additionally, in another embodiment of the food product or dietary supplement, the fatty acid composition is produced from a marine oil, such as fish oil. Furthermore, it should be noted that the fatty acid composition is preferably applied to humans or animals by oral administration. However, the food or dietary supplement of the invention may also be produced in a form that can be administered by any other route, such as intravenous, subcutaneous, intramuscular, intranasal, rectal, vaginal or topical administration, etc., where the active ingredient is effectively absorbed and utilized. The fatty acid composition may also be partly an emulsion comprising at least a liquid oil, and the food or dietary supplement may be applied as a liquid nutrition or a beverage.

In a preferred embodiment of the invention, the intake of the human or animal food or dietary supplement is performed together with the reduction of caloric intake. The animal is a pet or a horse. Reducing caloric intake may also be suitably performed in conjunction with physical exercise. If a human or animal applies the food or dietary supplement of the invention in combination with a reduction in caloric intake, weight loss will be more effective. In addition, in another embodiment of preventing weight gain, the intake of human or animal food or dietary supplements is also performed in conjunction with the reduction of caloric intake. Mild caloric restriction, preferably a 5-20% reduction in calories in the daily diet, together with the use of the fatty acid composition of the present invention appears to have an additive effect on preventing weight gain. Thus, in a preferred embodiment of the invention, the treatment with the fatty acid composition is combined with at least 5% caloric restriction. In a more preferred embodiment, the treatment with the fatty acid composition is combined with 10-15% caloric restriction. As stated above, this may correspond to the FDA definition of sustained weight loss, i.e., 10% loss over the course of a year. It has been unexpectedly discovered from the present studies that a combination of about 10% caloric restriction with treatment with a fatty acid composition of the present invention prevents weight gain in obese animals.

In another preferred embodiment of the invention said fatty acid composition is administered in a daily dose of 10-40% of the total amount of lipids in a daily diet for human or animal use. This means that 10-40% of the total daily dietary lipid may be replaced by the fatty acid composition according to the invention.

In another preferred embodiment of the invention, the fatty acid composition comprising DHA or EPA in combination with DHA is administered in a dose providing a daily dose of the fatty acid composition of 1-15 g. In a more preferred embodiment, 2-10g of the fatty acid composition is applied per day, and in a most preferred embodiment, 2-6g of the fatty acid composition is applied per day. As mentioned above, the effect of the fatty acid composition of the invention appears to be very strong at high doses, preferably for weight loss. Furthermore, it should be noted that the treatment of overweight or obese animals or humans with a low dose of the fatty acid composition of the invention will inhibit or prevent weight gain.

In another preferred embodiment, the food or dietary supplement is in the form of a capsule, preferably a flavored capsule. This embodiment also includes a capsule wherein the capsule and the fatty acid composition contained within the capsule, preferably a fish oil, are flavored. By adding flavor to the capsule as above, the product will be more appealing to the user.

In addition, weight loss is not achieved by humans only during fasting periods. A reasonable weight loss program should also take into account the measurement of energy expenditure and personalized dietary recommendations.

Thus, according to a fourth aspect of the present invention, the present invention relates to a dietary product comprising a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or combinations thereof, for the non-pharmaceutical treatment and/or prevention of obesity, an overweight condition and/or the assistance and control of weight loss and/or prevention of weight gain.

In a preferred embodiment of the invention, a dietary product comprising a fatty acid composition comprising (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or a derivative thereof or a combination of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA) or a derivative thereof and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) for the non-pharmaceutical treatment and/or prevention of obesity, an overweight condition and/or for aiding and controlling body weight loss and/or for inhibiting body weight gain, wherein the weight ratio EPA: DHA in the fatty acid composition is 1: X, wherein X is equal to or greater than 1. Preferably, the fatty acid composition has DHA or a derivative thereof as the main active ingredient.

In another embodiment of the invention, the dietary product is a weight control product or a weight loss product.

In another embodiment of the dietary product, the composition comprises a combination of EPA and DHA, or derivatives thereof, wherein EPA to DHA is about 1:1 to 1:8, and EPA to DHA is preferably about 1:1 to 1: 6.

In another embodiment of the dietary product, at least one of EPA and DHA is derived from at least one of plant, microbial and animal origin or a combination thereof. The fatty acid composition is preferably produced from a marine oil, such as fish oil. In order to promote and increase the weight loss effect, it is appropriate to combine the intake of the dietetic product with a reduced caloric intake of the person and/or with physical exercise.

In a preferred embodiment of the dietary product, the fatty acid composition is administered in a daily dose corresponding to at least 10% of the total lipid content of a daily diet for a human or an animal.

Furthermore, the dietary product may be in the form of a bar, a snack, or e.g. a beverage, comprising the fatty acid composition according to the invention.

According to a fifth aspect, the present invention relates to the use of a fatty acid composition comprising at least one of EPA or derivatives thereof and DHA or derivatives thereof, or combinations thereof, in the manufacture of a dietary product for controlling and assisting weight loss and/or preventing weight gain in a human.

In a preferred embodiment, the fatty acid composition comprising (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or a derivative thereof or a combination of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA) and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) is used in the manufacture of a dietary product for preventing weight gain and/or controlling body weight and for assisting weight loss in a human, wherein the weight ratio EPA: DHA in the fatty acid composition is 1: X, wherein X is equal to or greater than 1. Furthermore, it has been found from the studies of the present invention that fatty acid compositions enriched in DHA may achieve the most preferred effects of the present invention in weight loss and prevention of weight gain. One particular application of the fatty acid composition of the present invention is the incorporation of the fatty acid composition into a supplement product.

According to a sixth aspect, the present invention relates to a method of supplementing a dietary product comprising the step of adding a fatty acid composition comprising at least one of EPA or derivatives thereof and DHA or derivatives thereof, or combinations thereof, to a supplement product for controlling and assisting in weight reduction and/or preventing weight gain, preferably for humans.

In a preferred embodiment of the method of adding a dietary product, the invention relates to the step of adding a fatty acid composition to a supplement product, such as a weight control product or a weight loss product, the fatty acid composition comprising (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or a derivative thereof or a combination of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA) and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or a derivative thereof, wherein the weight ratio EPA: DHA in the fatty acid composition is 1: X, wherein X is equal to or greater than 1.

Most dietetic products on the market contain small amounts of saturated fatty acids. The present invention opens up the possibility of adding the fatty acid composition of the invention to new or existing dietetic products. In a preferred embodiment of the invention, fish oil is added to the dietetic product. This may therefore be a faster way to market a dietetic product, which functions to help, control and/or induce weight loss. And, further, a body weight control medicament comprising an effective amount of a fatty acid composition wherein the main active ingredients are at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA) or derivatives thereof and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA) or derivatives thereof, or combinations thereof, for the treatment and/or prevention of body weight loss or for the inhibition of body weight gain.

Furthermore, obesity, where the body has excess fat, is defined herein as a body mass index greater than 30, while being overweight is defined as a body mass index greater than 25. Obesity also includes visceral or systemic obesity due to genetic predisposition, sometimes described as being of the conservative genotype. Life history and living environment, such as high fat or high calorie diet or obesity due to lack of exercise, may also be treated according to the methods described herein. As used herein, the term "treatment" refers to both treatment for relief or palliation purposes and treatment for obesity or overweight, either acutely or chronically. Long-term treatment refers to treatment that is continued for weeks or years or more. In addition, the present invention also includes the prevention of weight gain by the use of the fatty acid composition of the present invention. As used herein, preventing weight gain also refers to inhibiting weight gain and affecting or controlling weight loss.

Brief description of the drawings

In the following studies and examples, reference is made to the accompanying figures, where all numbers are from a study of mice. The study was conducted to show that treatment with a fatty acid composition comprising at least one of EPA and DHA or any combination thereof can reduce body weight and/or prevent body weight gain under certain conditions. In the drawings to which reference is made:

FIG. 1A shows the composition of a semi-synthetic high fat diet (20% w/w fat) applied to different groups of mice, one containing linseed oil and EPAX2050TG (Ln + FO) and the other containing linseed oil and no EPAX2050TG (Ln). Figure 1B shows the total body weight of mice treated one month after treatment with a meal containing linseed oil and EPAX2050TG (Ln + FO) and a meal containing linseed oil only and no EPAX2050TG (Ln), as well as a meal containing lard and EPAX2050TG (L + FO) and a meal containing lard only and no EPAX2050TG (L).

Figure 2A shows the composition of a semi-synthetic high fat diet (20% w/w fat) applied to different groups of mice containing linseed oil (Ln), linseed oil and high dose EPAX2050TG (Ln + FO) and linseed oil and low dose EPAX2050TG (Ln + FO low), respectively. Figure 2B shows the total body weight after two months of treatment.

Figures 3A and 3B show the compositions (% w/w) of semi-synthetic high fat (20% fat) diets applied to different groups of mice, containing linseed oil (Ln), corn oil (K), EPAX1050TG (bulk DHA) (D), EPAX4510TG (bulk EPA) (E), corn oil + EPAX1050TG (K + D), and corn oil + EPAX4510 (K + E), respectively, as the compositions of semi-synthetic diets (total energy% of diet) for the standard diet (ST). Figure 3C shows the food consumption per animal per day during an 8 week treatment period. Figure 3D shows total body weight 2 months after treatment compared to control (ST).

FIG. 4 shows the reduction of DNA. Furthermore, fig. 5A shows the energy content of a standard miscellaneous (chow) meal (ST), a timed HF (high fat) meal (called a fat-extended meal) and a semi-synthetic high fat (20% fat) meal. In addition, figure 5B shows weight loss and prevention of weight gain in mice fed either with HF composite diet, with no further modification (filled circles), or EPAX1050TG instead of 15% fat content (open circles), or EPAX1050TG (rich in DHA) instead of 44% fat content (filled triangles), or mice fed with Caloric Restriction (CR) regimen, either with HF composite diet alone (open triangles), or with diet formed with EPAX1050TG for 15% of the lipids in the diet (filled squares).

Figure 5C shows the dose-dependent effect of omega-3 product added to timed HF fattening diet in the case of obesity progression.

Finally, figure 6 shows the effect of EPAX1050TG and 10% caloric restriction on body weight.

Description of the preferred embodiments

A number of preferred embodiments of the present invention were carried out to demonstrate treatment with a fatty acid composition comprising at least one of EPA and DHA, or a combination thereof, to reduce body weight and/or prevent body weight gain.

In a first preferred embodiment, the effect of an omega-3 fatty acid composition containing about 20% EPA and 50% DHA (by weight) on body weight is investigated.

In a second preferred embodiment, the effect of the dose of the omega-3 fatty acid composition enriched with DHA (here represented by a fatty acid composition comprising about 20% EPA and 50% DHA) on body weight loss was investigated. In a third embodiment of the invention, the potential differences in action between a DHA-rich omega-3 product, an EPA product and a vegetable oil containing omega-6 fatty acids were investigated. In the fourth and fifth embodiments of the invention, the potential differences in action between a DHA-rich omega-3 fatty acid product and an EPA-rich omega-3 fatty acid product were investigated.

In a sixth embodiment of the invention, the effect of omega-3 fatty acid compositions on the prevention of obesity and body weight gain was investigated.

Finally, in a seventh study, the additive and weight loss between caloric restriction and omega-3 fatty acid composition under conditions of obesity progression was evaluated.

Examples

Experiments performed on mice:

seven different experiments were performed on mice to study various treatments to reduce body weight and/or prevent weight gain.

In studies 1-5, adult male mice (C57 BL/6J mice) were randomized to different types of semi-synthetic high-fat diets, and the fat content of these high-fat diets was varied in the respective studies. In the last two studies, adult male mice (C57 BL/6J mice) were randomized to fattening HF (high fat) diets (35% wt/wt total lipid content), altering the fat content in these diets.

Study 1: weight loss

In a first study, the effect of the omega-3 fatty acid composition containing EPA and DHA on body weight was studied. A mixture of about 20% EPA and 50% DHA is used. Adult male mice (C57 BL/6J mice) fed standard diet (4% fat) were randomized (n = 7) with one of four different types of semi-synthetic high-fat (20% fat) diets, wherein the fat component was 1) lard (L) in group, 2) lard plus EPAX2050TG (L + FO: EPAX2050TG 44% w/w of total lipid content), 3) linseed oil (18: 3n-3 about 50% of total lipid content; ln) and 4) linseed oil plus EPAX2050TG (Ln + FO; EPAX2050TG represents 44% w/w of the total lipid content). FO here refers to the various EPA and DHA concentrations used in these studies (e.g. EPAX with high DHA versus EPAX with high EPA). The animals were fed the different diets described above in one month and the composition of the feed was shown in figure 1A, which feed contained linseed oil and EPAX2050TG (Ln + FO) or linseed oil without EPAX2050TG (Ln). As shown in fig. 1B, after the study, group 2 (L + FO) had a reduced overall weight compared to group 1 (L); overall weight was reduced for group 4 (Ln + FO) compared to group 3 (Ln), and the difference between group 4 and group 3 was statistically significant. The body weights of the mice in each group before treatment were similar. Mice given linseed oil plus EPAX2050TG showed about a 10% reduction in body weight compared to mice given linseed oil alone.

This study shows that treatment with a fatty acid composition comprising EPA and DHA, wherein the amount of DHA is ≧ the amount of EPA, results in weight loss.

Study 2: bodyWeight reduction

In a second study, the effect of a dose of omega-3 fatty acid composition containing a combination of EPA and DHA (approximately 20% EPA and 50% DHA) on body weight loss was studied. A group of adult male mice (n = 7) fed a standard assorted diet (4% fat) was randomly assigned one of three different types of semi-synthetic high fat (20% fat) diets for two months. In this experiment, the fat components were 1) linseed oil (Ln) in group, 2) linseed oil in group with high dose EPAX2050TG (Ln + FO; EPAX2050TG at 44% w/w of total lipid) and 3) flaxseed oil plus low dose EPAX2050TG (Ln + FO low; EPAX2050TG represents 15% w/w of the total lipid content). The dietary compositions shown in figure 2A contained flaxseed oil (Ln), flaxseed oil and high dose EPAX2050TG (Ln + FO) and flaxseed oil and low dose EPAX2050TG (Ln + FO low), respectively. Figure 2B shows a total body weight loss in only 2 groups administered flaxseed oil and a high dose of EPAX2050TG at the end of the study.

The results of the second study are consistent with the first study, with weight loss in the group using a fatty acid composition with a weight ratio of DHA ≧ EPA. In addition, the results of this study also show that the administration of a fatty acid composition rich in DHA to rats fed a high fat diet did not produce a significant reduction in body weight at very low doses.

Study 3: weight loss

In this study, potential differences in the effect between DHA-rich omega-3 products (here represented by a fatty acid composition containing approximately 10% EPA and 50% DHA (EPAX 1050TG concentration)), EPA products (here represented by a fatty acid composition containing approximately 45% EPA and 10% DHA; EPAX4510 TG) and omega-6 fatty acid-containing vegetable oils were studied. Adult male mice (C57 BL/6J mice) fed a standard assorted diet (4% fat) were randomly assigned one of six different types of semi-synthetic high fat (20% fat) diets (n = 7) wherein the fat component was, 1) linseed oil (plant omega-3) (Ln), 2) corn oil (plant omega-6) (K), 3) EPAX1050 (DHA-rich) (D), 4) EPAX4510TG (EPA-rich) (E), 5) corn oil + EPAX1050TG (K + D), and 6) corn oil + EPAX4510 (K + E). A control group was also included, which was maintained on a standard diet (-ST). The animals were fed different diets over two months. These dietary compositions are shown in figures 3A and 3B. As can be seen in figure 3C, the food consumption was about 70 KJ/day/animal for 8 weeks of treatment. The results of fig. 3D show that treatment with a fatty acid composition comprising at least one of EPA and DHA, or a combination thereof, results in weight loss. Weight loss was obtained in animals fed EPAX1050TG (fatty acid composition rich in DHA), whereas less weight loss was obtained in animals fed EPAX4510TG (fatty acid composition rich in EPA) plus corn oil (44% of the total fat content in the product). However, EPAX1050TG (DHA-rich) is more potent than EPAX4510 TG. Furthermore, the body weight of mice fed corn oil plus EPAX1050TG (DHA-enriched) was reduced by about 15% (wt). These animals do not tolerate a high fat (20%) semisynthetic diet, with only EPAX1050TG (DHA-rich) being the sole lipid component. Of 7 mice fed EPAX1050TG, only 1 survived more than 4 weeks on this diet. These mice become thin. All mice fed a diet containing EPAX4510TG alone survived but appeared unhealthy.

The results of the third study showed that the weight-reducing effect of the fatty acid composition containing about 10% EPA and 50% DHA (fatty acid composition rich in DHA) was stronger than the effect of the fatty acid composition containing about 45% EPA and 10% DHA (fatty acid composition rich in EPA). In addition, the corn oil induced weight loss was similar to the effect of the fatty acid composition containing about 20% EPA and 50% DHA in linseed oil (in the first and second experiments), but was stronger than the effect of the fatty acid composition containing about 20% EPA and 50% DHA in lard (in the first experiment). The best way to apply products rich in DHA, preferably DHA ≧ EPA, is once again set forth above. These results also suggest that omega-3 products derived from seafood have a specific weight loss effect compared to vegetable oils (both omega-3 and omega-6) and saturated fats (lard).

Study 4: rich inFatty acid composition containing EPA and fatty acid composition rich in DHA Effect on weight loss

In this study, potential differences in the effect between DHA-enriched omega-3 products (here represented by a fatty acid composition containing approximately 10% EPA and 50% DHA (EPAX 1050TG concentration)) and EPA products (shown as a fatty acid composition containing approximately 45% EPA and 10% DHA; EPAX4510 TG) were studied. At 4 months of age, mice fed the mixed diet were divided into 2 groups (n = 7) and fed a semisynthetic HF diet based on corn oil (20% wt/wt total lipid content), either EPAX4510TG (EPA-rich) or EPAX1050TG (DHA-rich) instead of 44% (wt/wt) fat mass. The addition of both types of omega-3 PUFA products to the diet resulted in weight loss after two months of each feeding, as shown in Table 1 below.

The difference in b compared to HF is statistically significant.

Table 1: effect of omega-3 PUFA on body weight of mice fed a semi-synthetic HF diet based on corn oil.

However, the DHA-rich product EPAX1050TG had a stronger effect on weight loss than EPAX4510 TG. In addition, the results of this study demonstrate that EPAX enriched in DHA has a significant effect in helping to reduce body weight.

Study 5:fatty acid composition rich in EPA and fatty acid composition rich in DHA Effect on DNA reduction

In this study, the potential difference in action between a DHA-enriched omega-3 product (here represented by a fatty acid composition containing approximately 20% EPA and 50% DHA (EPAX 1050TG concentration)) and an EPA product (here represented by a fatty acid composition containing approximately 45% EPA and 10% DHA; EPAX4510 TG) was studied. At 4 months of age, mice fed the mixed diet were divided into 3 groups (n = 7) and fed a semi-synthetic HF diet based on linseed oil (alpha-linoleic acid constitutes about 50% of the total lipid content), either with EPAX4510TG (EPA-rich; hatched bars) or EPAX2050TG (DHA-rich; black bars) or semi-synthetic HF diet only (open bars) instead of 30% (wt/wt) fat mass. After one month of each feeding, the DNA was analyzed. The addition of the omega-3 PUFA product enriched with DHA (EPAX 2050 TG) to the diet caused a decrease in DNA, which indicates a decrease in the number of adipocytes, see fig. 4.

Thus, the DHA concentrate and/or the DHA-rich fatty acid composition of the invention may cause a DNA reduction, which appears to indicate a reduction in the number of adipocytes in adipose tissue (i.e., the adipocytes are killed).

Study 6: preventing weight gain and obesity

In a sixth study, the effect of omega-3 fatty acid compositions containing a combination of EPA and DHA (approximately 20% EPA and 50% DHA) on prevention of obesity and body weight gain was studied. Adult C57BL/6J male mouse groups (n = 7) were placed in a controlled environment (20 ℃, 12 hours light-dark cycle, 6:00a.m. turned on) and were freed to obtain water and a standard miscellaneous feed rich in sunflower oil, as the main lipid component, and containing negligible LC ω -3 PUFA. At 4 months of age (-2 weeks), the standard miscellaneous diet was replaced with HF (high fat) diet or a diet referred to herein as enriched HF diet (35% wt/wt total lipid), the diet composition of which is shown in figure 5A. The energy density of the HF composite diet was 22.3 kJ/g. When mice are provided with this HF (high fat) complex diet, their body weight increases at a much higher rate than mice that still maintain standard assorted feed feeding. After two weeks (week 0), the animals were divided into 5 subgroups and fed the HF complex diet ad libitum, either without any change (filled circles), or with EPAX2050TG instead of 15% fat mass (wt/wt; i.e. EPA + DHA forms 9% dietary lipids; open circles), or EPAX2050TG (rich in DHA) instead of 44% fat mass (wt/wt; EPA + DHA forms 26% lipids; filled triangles), see table 2 below.

a) The amount of EPA and DHA in the different products is expressed as g EPA/g DHA in 100g product.

b) Percentage of lipid component (wt/wt) in the diet replaced by the omega-3 PUFA product.

c) Part of the lipid component replaced by the HF complex diet (35% wt/wt total lipid) and the EPAX1050 product

Mice receiving a heat limitation (CR) regimen (30% calorie limit compared to the same diet ad libitum) were fed either only a HF-complex diet (open triangles) or a diet in which EPAX1050TG constituted 15% (wt/wt) of the lipids in the diet (i.e., EPA/DHA replaced 3g of 35g of lipids per 100g of diet, approximately 9% of lipids; filled squares).

The results of this study are shown in figure 5B. Weight gain was evident after approximately 2 weeks following the HF diet and reached around 6.5g in the next 5 weeks of the experiment. Mice fed the omega-3 product EPAX1050TG (rich in DHA) instead of the 15% lipid in the diet gained approximately 2.7g less weight than mice fed the HF complex diet alone. This indicates that even low doses of omega-3 product (only 15% wt/wt of the fat mass in the diet) can slow the development of obesity in ad libitum fed mice. EPAX1050TG replaced 44% of lipid during the 5 week feeding period with a net reduction in body weight of around 3 g. Under these conditions, the omega-3 group lost weight during the 5 week treatment period, while the control group (regular HF diet) increased weight. The above results show the dose-dependent effect of omega-3 products in addition to conventional HF fattening diet and that even small doses of fatty acid composition rich in DHA can reduce body weight gain after 5 weeks of treatment under conditions of obesity development. See the summary in fig. 5C.

From this study it is clear that 30% caloric restriction in animals fed HF complex diet resulted in a net weight loss during the 5 week treatment period; whereas EPAX1050 incorporated into the diet of CR animals had only a small effect on weight loss compared to animals receiving 30% CR, i.e. only additive effects on weight loss. Therefore, the interaction between CR and omega-3 products was investigated in more detail in the following studies. It is also noted that the omega-3 product instead of dietary lipids does not appear to affect the food consumption of the animals.

Furthermore, the results of this study show that the use of a fatty acid composition enriched in DHA at low doses significantly inhibits or prevents weight gain. The high dose DHA-rich fatty acid composition not only significantly inhibits or prevents body weight gain but also has a body weight reducing effect in case of obesity development. Thus, the dose of EPAX1050TG required to counteract weight gain in the case of dietary obesity is less than that required to maintain the animal's body weight relatively stable for weight loss on receiving the HF semi-synthetic diet. It is clear that obesity development makes the body more susceptible to the weight loss effects of fatty acid compositions containing EPA and DHA. In addition, the above experiments show a significant reduction in obesity in mice fed a complex diet containing long chain omega-3 fatty acids HF. This study shows that the treatment of obese or overweight animals with a fatty acid composition comprising EPA and DHA, wherein the amount of DHA is ≧ the amount of EPA, also prevents weight gain. The effect of preventing weight gain also means that obesity or overweight can be prevented.

Study 7: weight loss in the body under conditions of obesity development and Caloric Restriction (CR) and omega-3 Additive effect of fatty acid composition

In previous studies, the effect of caloric restriction and DHA-rich fatty acid composition on body weight loss under obesity development conditions was not fully evaluated. Therefore, supplementary studies were carried out on the interaction between caloric restriction and omega-3 products during the development of obesity in mice, represented by the DHA-enriched omega-3 product (EPAX 1050 TG), which contains about 10% EPA and 50% DHA. A group of C57BL/6J male mice (n = 7) were placed in a controlled environment (20 ℃, 12 hours light-dark cycle, 6:00a.m. turned on) and were freed to gain access to water and standard miscellaneous feed. At 4 months of age, the animals were randomized to a high HF (high fat) diet, the composition of which is shown in fig. 4A. After two weeks of adherence to the diet (week 0), the animals were divided into 4 groups: a) feeding HF compound diet at will; b) feeding a HF composite diet and performing 10% caloric restriction compared to (a); c) (iv) ad libitum feeding a HF complex diet wherein 15% of the fat in the diet is replaced by EPAX1050 TG; and d) ad libitum feeding a HF composite diet wherein 15% of the fat in the diet is replaced by EPAX1050TG and 10% of the diet is restricted compared to (a). The animals were fed different diets over 5 weeks.

Figure 6 the results show that treatment with a fatty acid composition comprising at least one of EPA and DHA or a combination thereof significantly reduces the increase in body weight under conditions of obesity development compared to mice fed a fattening HF diet alone. Unlike previous studies, mild caloric restriction reduced obesity development. Here, the difference between free HF and free HF + EPAX is statistically significant (paired t-test, P.ltoreq.0.03). In addition, the combination of the two treatments, i.e. 10% of the diet restriction and 15% of the dietary fat replaced by EPAX1050TG, had an additive effect in preventing weight gain compared to control mice fed the HF diet.

The results of the seventh study showed that a fatty acid composition rich in DHA increased the effect of Caloric Restriction (CR) on the development of obesity in animals fed HF composite diet (i.e., this condition mimics obesity in humans consuming excessive amounts of high fat diet). The high food intake renders the animal or human more susceptible to the effects of a fatty acid composition comprising at least one of EPA and DHA or a combination thereof, and the additive effect of the fatty acid composition with caloric restriction seems to be necessary in preventing weight gain, the composition comprising at least one of EPA and DHA or a combination thereof. This indicates that the fatty acid composition not only reduces body weight but also prevents body weight gain and obesity, the composition containing at least one of EPA and DHA or a combination thereof. The best mode of the invention can again be achieved with products rich in DHA, preferably DHA ≧ EPA. In addition, these results also opened a more manageable caloric restriction regimen for humans, since low dose caloric restriction showed both effects.

Dosage of fatty acid composition

With respect to the relative amounts of the fatty acid compositions of the present invention, the human dose can be estimated from the results of the mice, for example, a fatty acid composition comprising EPA and DHA or a combination thereof. In the previous studies, a semi-synthetic diet containing 20% (w/w) fat was used and its effect on body weight loss was observed when the fatty acid composition of the invention replaced at least 28% of the fat mass (by the addition of the fatty acid composition of the invention), whereas it had little effect on body weight loss when the composition of the invention constituted 9% of the lipid content of the diet. 40% of the energy of these diets comes from lipids.

The relative amount of the fatty acid composition of the invention in the total amount of lipids (in the diet) may be more important than the absolute intake in terms of its effect on weight loss. Thus, one embodiment of the invention is a fatty acid composition of the invention comprising at least one of DHA and EPA, or a combination thereof, in place of at least 1/3 of the total amount of lipids. See below for several related schemes.

1. One person consumed 1000 calories per day on a low calorie diet, with 18% of the calories coming from fat. In order to replace 28% of the total intake of 20g of lipid with the fatty acid composition according to the invention, the person needs 5.6g fatty acid composition/day.

There is a hypothetical synergistic effect of caloric restriction and the fatty acid composition of the present invention on weight loss, so low concentrations of this fatty acid composition in dietary lipids also have an effect on weight loss.

In another embodiment of the invention, the fatty acid composition of the invention replaces at least 15% of the fat mass of the diet. This means that about 3g of the fatty acid composition is ingested per day in a very low calorie diet, which has 1000 calories per day, of which 18% are from fat.

In a preferred embodiment of the invention, the treatment and/or prevention of obesity or overweight, or the control of body weight and/or the prevention of weight gain according to the invention is carried out together with a reduction in caloric intake of a human or animal. The diet regimen for calorie reduction is preferably combined with physical exercise.

In another embodiment of the invention, for short term rapid treatment of obese patients (adults), the reduced caloric intake will be reduced to at least 800 calories (2520 KJ/day) or less. In a more preferred embodiment, the fatty acid composition comprising at least one of EPA, derivatives thereof and DHA, or derivatives thereof, or any combination thereof, is administered in a daily dose of (corresponding to) 10-40% of the total lipid content of a human daily diet. Moreover, to obtain better results, the amount of lipids in the diet can be reduced to at least 15% of its energy. The fatty acid composition of the present invention is preferably administered in divided doses daily for 1 to 5 years. In another aspect, the fatty acid composition of the invention is also related to the amount of omega-3 fatty acids consumed by, for example, an Eschleman or near-indigenous ethnic group. Thus, in another embodiment of the invention, the fatty acid composition comprising at least one of EPA and DHA or derivatives thereof, or combinations thereof, is administered in a daily dose of 1g to 15 g. More preferably the dose is 1-10 g/day, most preferably 2-6 g/day.

Discussion of the related Art

The results show that the fatty acid composition comprising at least one of EPA and DHA or any combination thereof reduces body weight and/or prevents body weight gain. The DHA-enriched product of the invention has a greater weight-reducing effect than products containing more EPA than DHA. Furthermore, the fatty acid composition derived from seafood according to the invention preferably achieves a specific body weight reducing effect and a specific body weight gain preventing effect. In addition, based on these results, dose calculations and market value, the fatty acid composition of the present invention may preferably be used in combination with a reduced calorie regimen. Furthermore, the fatty acid composition of the present invention may be used in combination with caloric restriction to achieve an additive effect under conditions of high food intake and development of overweight or obesity. It is clear that with the fatty acid composition according to the invention it is desirable to obtain the same body weight reducing effect and/or body weight gain preventing effect on both humans and animals.

In addition, the DHA-concentrate and/or the fatty acid composition enriched in DHA according to the invention may reduce the number of adipocytes in adipose tissue.

The reduction of body weight and/or prevention of body weight gain by the use of the fatty acid composition according to the invention may at least partly be due to an increased oxidation of lipids (fatty acids) inside the cells of human or animal adipose tissue, which composition is preferably a fatty acid composition rich in DHA. Thus, a fatty acid composition, preferably rich in DHA, induces the opening of a metabolic switch in adipocytes (fat cells), which seems to prevent the accumulation of body fat. The switch may be activated by direct interaction of a fatty acid composition of the invention, preferably a fatty acid composition rich in DHA, with adipocytes by inducing mitochondrial genes to control oxidative capacity. Transcription factors that coordinate mitochondrial biogenesis (PGC 1 and NRF 1) appear to be involved. Changes in gene expression appear to cause increased levels of mitochondrial components that are critical for oxidation of various substrates in adipocytes, including lipids. In addition, the fatty acids of the present invention can increase the rate of fatty acid oxidation and synthesis activity in adipose tissue, thereby activating metabolic switches.

The invention should not be limited to the embodiments and examples shown.

Claims (51)

1. Use of a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof, for the manufacture of a medical product for controlling weight loss, preventing weight gain, and treating and/or preventing obesity or an overweight condition.

2. Use according to claim 1, wherein the weight ratio of EPA to DHA in the fatty acid composition is 1: X, where X is equal to or greater than 1.

3. Use according to claim 1, wherein the combination of EPA and DHA in the composition is present in a ratio EPA: DHA of from 1:1 to 1:8, preferably EPA: DHA of from 1:1 to 1: 6.

4. Use according to claim 1, wherein the fatty acids in the composition are present in at least one of esterified form, ethyl ester form, salt form and free acid form or any combination thereof.

5. Use according to claim 1, wherein at least one of EPA and DHA is derived from at least one of plant, microbial and animal origin or a combination thereof.

6. Use according to claim 1, wherein at least a part of the EPA and/or DHA is produced from a marine oil, preferably a fish oil.

7. Use according to claim 1, wherein the fatty acid composition is produced from a marine oil.

8. Use according to claim 1, wherein the fatty acid composition consists of a combination of EPA and DHA in triglyceride form.

9. Use according to claim 1, wherein the fatty acid composition is administered orally to a human or animal.

10. Use according to claim 1, wherein the treatment is applied to the human or animal in combination with a reduction of caloric intake.

11. Use according to claim 1, wherein the fatty acid composition is administered in a daily amount of between 10 and 40% of the total lipid content of a daily diet for human or animal consumption.

12. Use according to claim 1, wherein the fatty acid composition is administered to a human in an amount of 1g to 15g, preferably 2 to 6g, of the fatty acid composition per day.

13. A method for the treatment and/or prevention of obesity, an overweight condition or for controlling body weight reduction and/or preventing body weight gain, wherein an effective amount of a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof, is administered to a human or animal.

14. The method according to claim 13, wherein the weight ratio of EPA to DHA in the fatty acid composition is 1: X, where X is equal to or greater than 1.

15. The method of claim 13, wherein the combination of EPA and DHA in the composition is present in a ratio of EPA: DHA from 1:1 to 1:8, preferably EPA: DHA from 1:1 to 1: 6.

16. The method of claim 13, wherein the fatty acids in the composition are present in at least one of esterified form, ethyl ester form, salt form, and free acid form, or any combination thereof.

17. The method of claim 13, wherein the fatty acid composition consists of a combination of EPA and DHA in triglyceride form.

18. The method of claim 13, wherein at least one of EPA and DHA is derived from at least one of plant, microbial, and animal origin.

19. The method according to claim 13, wherein at least a part of the EPA and/or DHA is produced from a marine oil, preferably a fish oil.

20. The method of claim 13, wherein the fatty acid composition is administered orally to a human or animal.

21. The method of claim 13, wherein the treatment is applied to the human or animal in combination with reducing caloric intake.

22. A method according to claim 13, wherein the fatty acid composition is administered in a daily amount corresponding to at least 10% of the total lipid content of a daily diet for a human or an animal.

23. Use of a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof, in the manufacture of a food product or dietary supplement for controlling and assisting in weight reduction and/or preventing weight gain.

24. Use according to claim 23, wherein the weight ratio EPA: DHA in the fatty acid composition is 1: X, where X is equal to or greater than 1.

25. Use according to claim 23, wherein the combination of EPA and DHA in the composition is present in a ratio EPA: DHA of from 1:1 to 1:8, preferably EPA: DHA of from 1:1 to 1: 6.

26. The use of claim 23, wherein the fatty acids in the composition are present in at least one of esterified form, triglyceride form, ethyl ester form, salt form and free acid form, or any combination thereof.

27. Use according to claim 23, wherein the fatty acid composition consists of a combination of EPA and DHA in triglyceride form.

28. Use according to claim 23, wherein at least one of EPA and DHA is derived from at least one of plant, microbial and animal origin or a combination thereof.

29. Use according to claim 23, wherein at least a part of the EPA and/or DHA is produced from a marine oil, preferably a fish oil.

30. Use according to claim 23, wherein the fatty acid composition is produced from a marine oil.

31. Use according to claim 23, wherein the fatty acid composition is administered orally to a human or animal.

32. The use of claim 23, wherein the weight management, weight gain prevention and fat reduction is applied in combination with calorie intake reduction in a human or animal.

33. Use according to claim 23, wherein the fatty acid composition is administered in a daily amount corresponding to at least 10% of the total lipid content of a daily diet for a human or an animal.

34. The use of claim 23, wherein the food or dietary supplement is in the form of a capsule, which capsule is flavored.

35. Use according to claim 23, wherein the fatty acid composition is a liquid or an emulsion and the food or dietary supplement is used as a beverage.

36. Use according to claim 23, wherein the fatty acid composition is administered in a human amount of 1g to 15g, preferably 2 to 6g, of the fatty acid composition comprising DHA or a combination of EPA and DHA per day.

37. A dietary product comprising a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof, for the non-pharmacological treatment and/or prevention of obesity, an overweight condition and/or for assisting and controlling body weight loss and/or for preventing body weight gain.

38. A dietary product according to claim 37, wherein the weight ratio of EPA to DHA in the fatty acid composition is 1: X, where X is equal to or greater than 1.

39. A dietary product according to claim 37, wherein the main active ingredient is DHA.

40. A dietary product according to claim 37, wherein the dietary product is a weight control product or a weight loss product.

41. A dietary product according to claim 37, wherein the combination of EPA and DHA in the composition is in a ratio EPA: DHA of from 1:1 to 1:8, preferably EPA: DHA is present in a ratio of 1:1 to 1: 6.

42. A dietary product according to claim 37, wherein at least one of EPA and DHA is derived from at least one of plant, microbial and animal origin, or combinations thereof.

43. A dietary product according to claim 37, wherein the fatty acid composition is produced from a marine oil, preferably a fish oil.

44. A dietary product according to claim 37, wherein the intake of the dietary product is combined with a reduction in caloric intake and/or with physical activity in a human.

45. A dietary product according to claim 37, wherein the fatty acid composition is administered in a daily amount corresponding to at least 10% of the total lipid content of a daily diet for a human or an animal.

46. A dietary product according to claim 37, wherein the dietary product is a bar, snack or beverage.

47. Use of a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof, in the manufacture of a dietary product for preventing weight gain and/or controlling and assisting in weight loss in a human.

48. Use according to claim 47, wherein the weight ratio EPA to DHA in the fatty acid composition is 1: X, where X is equal to or greater than 1.

49. A method of supplementing a dietary product, comprising the step of adding a fatty acid composition comprising at least one of (all-Z omega-3) -5,8,11,14, 17-eicosapentaenoic acid (EPA), or derivatives thereof, and (all-Z omega-3) -4,7,10,13,16, 19-docosahexaenoic acid (DHA), or derivatives thereof, or any combinations thereof, to the supplemental product for preventing weight gain and/or for controlling and assisting weight loss in a human.

50. The method according to claim 49, wherein the weight ratio of EPA to DHA in the fatty acid composition is 1: X, where X is equal to or greater than 1.

51. The method of claim 49, wherein the fatty acid composition to be added to the supplemental product is present in a liquid or emulsion form.