GB2353471A

GB2353471A - Composition for treating obesity

Info

Publication number: GB2353471A
Application number: GB9915742A
Authority: GB
Inventors: Daniel Vigdorovich
Original assignee: Individual
Current assignee: Individual
Priority date: 1999-07-06
Filing date: 1999-07-06
Publication date: 2001-02-28
Anticipated expiration: 2019-07-06
Also published as: GB9915742D0; GB2353471B

Abstract

A composition for correction of impaired metabolism, and in particular for treating obesity and related disorders comprising natural substances for restoring balance in processes of excitation and cortical inhibition, amino acid, source of short chain fatty acids, calcium, and vitamin. The ingredients specifically mentioned include : <SL> <LI>(a) natural substances : extracts of <U>Adonidis vernalis</U> and <U>Leonuri sp.</U> , sodium or potassium bromide, magnesium sulphate and sodium or potassium iodide : <LI>(b) amino-acid : alanine ; <LI>(c) short chain fatty acid : butter, coconut oil or palm oil ; <LI>(d) calcium : calcium dihydromonophosphate or calcium glycerophosphate ; <LI>(e) vitamin : vitamin B<SB>6</SB>. </SL>

Description

Composition for treating obesity and related disorders and using thereof

The present invention relates to a novel composition useful for correction of impaired metabolism, and in particular for treating obesity and related disorders. The invention further relates to the use of the novel composition for the prevention or treatment of weight gain in a human organism in need of such prevention or treatment. The said composition may be also used for the treatment of some neurological conditions characterized by impaired balance in processes excitation and cortical inhibition.

The problems of weight control, in particular normalization of the accumulation of fat, has long been an issue of concern.

According to the WHO presentation (Feature N190, March 1996) obesity, or overweight, together with smoking, stressful environment, excessive alcohol consumption and lack of physical activity form a group of lifestyle risk factors associated with increased morbidity and mortality from noncommunicable diseases, so that by the year 2020, they will account for about three-quarters of all deaths in the developing world. On the other hand, in many cases they are preventable.

According to the WHO estimation, up to 20% of Europeans and of whites in the US between 20 to 60 years of age are grade 2 overweight. This figure increases up to 40% for women in eastern European and Mediterranean countries and black women in the US. Up to 70 % of women on the island of Nauru in Micronesia are grade 2 overweight, while in India it is only 3 %.

At the same document it is claimed that more often than not, obesity is the result of unhealthy eating habits coupled with a sedentary way of life.

A reduction in caloric intake has long been used as an attempted treatment for obesity. Accordingly, absolute majority of the known compositions for prevention and treatment of obesity has as its goal to suppress appetite.

However, it is well documented that reduction in caloric intake soon reduces metabolic rate, which causes weight loss to slow down and even stop. Furthermore, after the caloric reduction is discontinued and an unrestricted diet is resumed, the slower metabolic rate causes rapid weight gain. As a result, most attempts at weight control through caloric restriction are unsuccessful or only moderately successful and any benefit is short lived (US Patent 5,760,047).

a 00 00 0 0 0 0 to During previous every day practice we were surprised that our recommended diet was more rich in calories than basic one used by our patients, and nevertheless about 60% of the patients had lost the weight successfully. In that cases the assortment of the food in recommended diet was quite different from basic one. Currently in order to understand the said process we recommended to our obese patients during 3 to 7 days to register food intake by items, quantity, time and place, and to weight themselves and to measure some circumferences. During the next period up to 3 weeks they ate according to the same plan, but from about 1.5 to about 2 times more food. The great majority of patients subjected to this procedure did not change neither their weight nor circumferences. About 5% of the patients from the first days started to lose weight. About 20% of the patients during the first week, or so, gained their weight from about 1 to about 6 kg. But keeping the same diet plan all of them during the next 2 weeks returned back to initial weight or had lost some kilograms in comparison to initial weight. From this observation we concluded that energy intake does not affect body fat content. On the other hand, both psychic and physiologic aspects of hunger play their role in converting metabolism to thrifty type. From this point of view it is very important not only to intake enough amount of all kinds of nutrients, but also to destroy stereotype of the hungry diet plan.

In the most of our patients impaired balance in processes excitation and cortical inhibition was diagnosed. Correction of the said balance improved both the condition of patients and the outcome in losing weight.

On the other hand, in our observations the stress was the most important of the decreasing success factors. Furthermore stress is the most important factor hindering to maintain successful result. We use the term "stress" as reactions of the body to forces of a deleterious nature, infections, and various abnormal states that tend to disturb its normal physiologic equilibrium (homeostasis). Sometimes any kind of stress may appear as only one reason of the obesity.

Activation of gluconeogenesis is used as one of the basic activity of the disclosed composition. This reaction is achieved by presenting excessive amount of the amino-acid, preferable I-alanine, in the composition. It is known, that by this way gluconeogenesis can by activated only in the starvation, otherwise amino-acid must be utilized alongside the release of energy or for protein construction. From one hand, the presence in the composition of substances for restoring balance in processes of excitation and cortical inhibition, and, from the other hand, of both calcium (preferable as calcii dihydromonophosphat, but also possible as calcii chiconatis, calcii glycerophosphatis or combination thereof) and vitamin B6 (preferable in combination with other vitamins of group B) allows to activate gluconeogenesis in any amount without starvation.

According to our clinical observation animal fats (first of all butter) play an important role for losing weight by the disclosed method. Supposedly, the role of butter depends on short- and middle-chain fattyacids. It is possible to use plant oil, for example coconut oil, palm oil or combination thereof, but in the disclosed method animal sources of the fatty-acids are preferable. Modern technology of the butter includes the usage of some artificial substances in many countries. Sometimes, it is dangerous, and diminishes therapeutic result. So, in order to obtain independence from source of the butter, high quality butter is included in the composition.

It is ascertained empirically that combination of extractum herbae Adonidis vernalis, extractum herbae Leonuri, natrii or ka1ii bromidum, magnesii sulfatis, and natrii or ka1ii iodidum, further comprising caffenum provide the high effective normalization of the said balance in the obese patients. It is more effective, than combination with Passiflora, and does not irritate the intestine in comparison to Valeriana. The next proportion provides the best result: for each I g of Extracturn h. Adonidis vernalis (1:1): Extractum h. Leonuri (1:1) from about 1.3 to about 7 g; Natrii bromidi from about 0.8 to about 3 g; Natrii iodidi from about 0.01 to about 0.3 g; Magnesii sulfatis from about 0.1 to about 0.6 g. It is reasonable to add plant extracts chosen from Panax ginzeng, Shizandra, Ehinophanaps, Eleuteraoccus, or combination thereof in individual cases.

Chemical incompatibility of some ingredients may be eliminated by micro encapsulation of the ingredients.

The said composition may be produced as pharmaceuticals with a pharmaceutically acceptable carrier or excipient, or as food supplement as well.

Composition disclosed herein allows to obtain the good result in normalizing the impaired metabolism in obese person only in the frame of the disclosed method of using thereof.

In order to predict the effectiveness of the disclosed method for any individual patient, and, if possible, to avoid any circumstances which can low the said effectiveness before the treatment by disclosed composition, some tests must be provided. Hypersensitivity to any food may be the only cause of the obesity. So, it must be tested by any kit, or by any method used in the clinical practice. If hypersensitivity to any food is revealed, hyposensibilisation by very small doses must be done. In the unforturi,ate result such 00 0 0 4,:00.00.0.

04.0 soso food must be eliminated. On the other hand, sometimes endocrine pathology may take place. In such cases hormonal replacement or anti -inflammatory therapy must precede the treatment by the said composition.

In order to plan correct scheme of treatment by the disclosed composition it is reasonable to diagnose the metabolic disorders causing the obesity in the patient, and determine the importance of etiologic factors in an individual patient. One of the ways to solve this problem is to subject the patient to some nutritional tests. For example, to use some monodiets with excessive amount of one nutrients in comparison to the others, and to evaluate the response on anthropometric feature (like loosing and regaining weight), and the patient's feeling (like duration after meals before hunger, headache, aftertastes, weakness, sickness.

Usage of the said composition may be successful only in combination with some elements of life style.

All food must be only natural one. It means the food must be prepared only from traditional food raw materials without any chemical treatment. Furthermore, the said food must be traditional one for an individual patient. Otherwise, the food causes the stress. In order to avoid nutritional stress the food must be tasteful, rich enough in energy, corresponding to the appetite, and the number of the food intake per day must be constant (from 3 to 6, as a rule 4 times a day). Nutrition must be seasonal one. Methods of the food preservation must be very limited by the condition that the treatment must be so safe that new chemical substances or isomers do not appear, excluding those that are a result of traditional for food production microorganisms activity. For prevention of the stress from food monotony phases of nutrition must be interchanged. The fat intake must be no less than 30 g per day, animal fat should be no less than 70% of the whole fat, and the butter should be no less than 30% of the whole fat, furthermore, as a source of essential lipids, in average at least I egg must be taken. The sources of the fat and oil must be only natural food raw materials. Excessive quantity of plant oil causes instability of the cell membranes.

In order to eleminate stress of non-nutrition factors sound therapy, psychotherapy, games and plays, collective entertainment, or combination thereof may be used.

Combination of the foodstuffs depends only on nutrients content. Pharmacologic actions of food obtained by excesses of one foodstuff in comparison to another are not used, because it may be additional sources of the metabolic stress.

so: 0 0 0000 0: " 0 0 On the other hand excessive amount of the natural metabolites in combinations with special elements of lifestyle may be used in the frame of the said method, for example, I-alanine of recipe may be combined with injections of glucagon and the walking in special tempo, so that the tempo of the walk would be accelerating gradually up to the tempo when the further acceleration would caused the pant, duration of the said walk must be no less than about 40 minutes including no less than about 30 minutes in the high tempo.

In order to create optimal streams of the nutrients an interval between meals must be depending on the food, but never should be less than 2.5 hours, because of cyclic nature of the stomach activity. Before breakfast must be taken carrot or cabbage juice. The breakfast must consist of the foods supplying by large amount of the energy immediately, and the said breakfast must follow no more than about 30 minutes after getting up, because in normal condition after night rest there is not enough energy to wake the organism up. As alternative to this principle of the building breakfast, meat products can be used. Lunch must be preferably rich in the fiber in order to obtain carrier for ingestion nutrients little by little during the day, for example, the breakfast may consist of the raw vegetables snacks with high content of the fiber. In the evening to eat less than 4 hours before going to bed must be avoid. The meals must be rich in protein, and poor in fiber, in order to avoid both excess of the energy in the night and the stereotype of hunger. In order to avoid stress during the early stages this meal may comprised from boiled vegetables.

Among obese people absolute majority patients have no full block of one or another metabolic way, but only limited pathway. So, if on the background of rich diet, while depots are rich, to use short period of the monodiet from time to time, for example, only apple juice during a day, or only yogurt during a day, -the number of the active pathways is much less than usually. It can give to the body possibility to organize the way in need much more effective.

Claims

1. A composition for prevention or treatment the obesity or related diseases including at least one natural substance for restoring balance in processes of excitation and cortical inhibition, at least one amino acid, source of short chain fatty acids, source of calcium, at least one vitamin, and at least one mineral.

2. The composition of claim 1, wherein sources of the said natural substances for restoring balance in processes of excitation and cortical inhibition are extractum herbae Adonidis vernalis, extractum herbae Leonitri, natrii or kalff bromidum, magnesii sulfatis, and natrii or kaIii iodidum.

3. The composition of claim 2, comprising for each 1 g of Extractilm h. Adonidis vernalis (1:1): Extractum h. Leonuri (1:1) from about 1.3 to about 7 g; Natrii bromidi from about 0.8 to about 3 g; Natrii iodidi from about 0.01 to about 0.3 g; Magnesii sulfatis from about 0. 1 to about 0. 6 g.

4. The composition of claim 2 or 3, further comprising natural source of caffeine.

5. The composition of claim 2, 3, or 4, further comprising a pharmaceutically acceptable form of plant selected from the group consisting of Panax ginzeng, Shizandra, Ehinophanaps, Eleuteraoccus, or combination thereof.

6. The composition of claim 1, wherein the said aminoacid is alanine.

7. The composition of claim 1, wherein the said source of short chain fat acids is selected from the group consisting butter, cocco nut oil, palm oil or combination thereof.

8. The composition of claim 1, wherein the said source of calcium is selected from the group consisting calchim dihydromonophospat, calcii cluconatis, calcii glycerophosphatis or combination thereof.

9. The composition of claim 1, wherein the said vitamin is vitamin B6.

10. The composition of claim 1, wherein the chemical compatibility of said composition being achieved due to the microencapsulation of its components.

11. The formula of claim 1, wherein the said composition is in a feed.

12. The formula of claim 1, wherein the said composition is administrated with a pharmaceutically acceptable carrier or excipient.

13. A method of treatment obesity by using the composition of claim I or 4 comprising of:

- prediction of the effectiveness of the said method for an individual patient, and, if possible, the clearance of any agent which can lower the said effectiveness; - diagnostic of the metabolic disorders causing the obesity in the patient, and determination of the importance of etiologic factors in the said patient; - prescription of the formula of claim 1; destruction of the chronic hunger and food limitation stereotype; providing actions for the stress relief in the patient; - determining that the said patient has used only natural and rich in nutrients food, furthemore the foodstuffs have to be combined according to nutritive peculiarity; - instructing the said patient regarding the style of nutrition; - using for the repair of metabolism interaction the excessive amount of natural metabolites, from one hand, and elements of lifestyle, on the other hand; - using monodiets.

14. A method of claim 13, wherein for prediction of the effectiveness of the said method for an individual patient, and, if possible, the clearance of any agent which can lower the said effectiveness, hypersensitivity to foodstuffs is diagnosed and, if the result is positive, hyposensitization is taken, and if the result cannot be achieved, such foodstuffs are eliminated form nutritional plan.

15. A:method of claim 13, wherein for prediction of the effectiveness of the said method for an individual patient, and, if possible, the clearance of any agent which can lower said effectiveness, the said patient is subjected to medical examination in order to evaluate endocrine disorders, and to correct it by hormonal replacement or anti - inflammatory therapy.

16. A method of claim 13, wherein for diagnostic of the metabolic disorders causing the obesity in the patient, and determination of the role of etiologic factors in the said patient, nutritional tests are evaluated.

17. A method of claim 16, wherein as nutritional tests monodiets with excessive amount of one nutrients in comparison to the others are used, and the response on anthropometric feature and the patient's feeling.

18. A method of claim 13, wherein the said destruction of the chronic hunger and food limitation stereotypy being by nutritional recording during from 3 to 7 days, and than the patient being instructed to eat quite the same as in nutritional records, but from about 1.5 to abour 2 times more, and anthropometric features being registrated during all the said period;

19. A method of claim 13, wherein providing actions for the stress relief in the patient by sound therapy, or by psychotherapy, or by games and plays, or collective entertainment, or combination thereof is beimg used.

20. A method of claim 13, wherein for prevention of the stress from food monotony phases of nutrition are interchanged.

21. A method of claim 13, wherein for prevention of the nutritional stress, only the usual food for an individual patient is used.

22. A method of claim 13, wherein for prevention of the nutritional stress, the food for an individual patient is being selected from the natural food so that it is as much pleasurable for him, as possible.

23. A method of claim 13, wherein as one of the elements of nutritional style being from 3 to 6 serving a day, preferable 4, and this number must be the same day by day.

24. A method of claim 13, wherein as one of the elements of nutritional style an interval between meals depends on food, but never appears less than 2.5 hours.

25. A method of claim 13, wherein as one of the elements of nutritional style, assortiment of the food being chosen from all the natural foodstuffs according to appetite, so as fat intake was no less than 30 g per day, animal fat would be no less than 70% of the whole fat, and the butter would be no less than 30% of the whole fat, furthermore, as a source of essential lipids, in average of at least I egg must be taken.

26. A method of claim 13, wherein as one of the elements of nutritional style, as juice of cabbage or carrot or their combination being used in the morning before meals.

I 0 0%. I I

27. A method of claim 13, wherein, as one of the elements of nutritional style, breakfast consists of the foods supplying large amount of the energy immediately, and the said breakfast must folow no more than about 30 minutes after getting up.

28. A method of claim 13, wherein, as one of the elements of nutritional style, lunch should preferably consist of the raw vegetables snacks whith the high content of fiber.

29. A method of claim 13, wherein, as one of the elements of nutritional style, dinner preferably consist of the high protein of animal food.

30. A method of claim 13, wherein, as one of the elements of nutritional style, the last serving being no less than about 4 hours before going to bed.

3 1. A method of claim 13, wherein, as one of the elements of nutritional style, quantity of the food id determined by appetite exclusively.

32. A method of claim 13, wherein, as using for the reparing of metabolism interaction of the excessive amount of natural metabolites, from one hand, and elements of life style on the other hand, subjecting the said patient to the long walk after I-alanine and glucagone intake, so that tempo of the walk would be accelerating gradually up to the tempo when the further accelerating would cause the pant, duration of the said walk must be no less than about 40 minutes including no less than about 30 minutes in the high tempo.