HK1190888B - Serum cholesterol lowering drink and an improved method for lowering cholesterol - Google Patents

Abstract

The invention relates to a drink and a drink portion with serum LDL cholesterol lowering effect and a pack containing them. The invention is also related to a method for lowering serum LDL cholesterol in a subject in need thereof, wherein the subject ingests the drink.

Description

Serum cholesterol lowering drinks and improved methods for lowering cholesterol

Technical Field

The present invention relates to the field of healthy edible products, in particular to a serum cholesterol lowering drink.

Background

Elevated serum total cholesterol levels and/or elevated LDL (low density lipoprotein) cholesterol levels are one of the major risk factors for cardiovascular disease. One of the first steps in improving serum cholesterol levels (profile) is lifestyle changes, including changes in diet and exercise. Food products enriched in components with cholesterol lowering effect over normal nutrients have been commercially available for some time. Representative examples are food products with added phytosterols and/or phytosterols. Food products containing added phytosterols and/or phytosterols are widely available and include, for example, margarine, spreads, dairy products (such as yogurt), and bread. Also drinks containing phytosterols and/or phytosterols are available.

Single dose fast drinks (shotdrink) containing phytosterols and/or phytosterols have become popular in recent years. In these drinks, the daily dose of phytosterols and/or phytosterols is incorporated into a small volume of drink, typically about 100ml or even less. These drinks are typically based on milk (dairymulk), drinkable yoghurt or soymilk with added flavouring agents (e.g. fruits, berries), sweeteners, and phytosterols and/or phytosterols. These drinks contain phytosterols and/or phytosterols either in esterified form (i.e. as fatty acid esters) or in free form.

WO2010/084240 discloses beverages containing plant stanol or plant sterol esters. Although this document mentions that these products may be used as a meal drink, it has now been shown that the cholesterol lowering effect under such conditions is not optimal.

Recent meta-analysis (Demonty et al, J.Nutr.)139(2009)271-284) indicated that: phytosterols and phytostanols have better cholesterol lowering efficacy when incorporated into solid foods (such as margarine or yoghurt) than in liquid foods (such as beverages). For liquid food formats (such as drinks), simultaneous ingestion of a solid meal is required to ensure optimal cholesterol lowering efficacy. Therefore, consumers are generally advised to use products containing phytosterols and/or phytosterols along with the diet for best cholesterol lowering efficacy.

Dounbus (Doornbos) et al (european journal of clinical nutrition (eur.j. clin.nutr.) (2006)60(3):325-33) investigated the cholesterol lowering efficacy of yogurt drinks enriched with single doses of phytosterols under two different consumption conditions, when consumed with (as part of) or without (before breakfast) meals. The LDL cholesterol lowering efficacy of the drink is not optimal if not consumed with the meal.

Currently, consumers are advised to consume a single dose of fast drink containing phytosterols and/or phytostanols along with a meal daily to ensure optimal cholesterol lowering efficacy. However, many consumers will prefer to consume their single dose fast drink as a snack rather than with a meal. With currently known formulations, cholesterol lowering efficacy is not optimal if not taken with a meal.

Disclosure of Invention

The present invention provides beverages containing phytosterols and/or phytosterols wherein the beverages are suitable for consumption as a snack and still have an ensured serum LDL cholesterol lowering efficacy.

The invention relates to a beverage with serum LDL cholesterol lowering effect. The beverage portion comprises from 0.8g to 15g of total phytosterol and phytostanol equivalents, of which from 0.10g to 3.0g are in free form, with the proviso that from 5.0% to 25% of these equivalents are in free form and the remainder of these equivalents are in esterified form. The drink portion further comprises from 2.5g to 15g of triglyceride fat, at least one additional edible ingredient, and water.

The invention also relates to a beverage with the function of reducing serum LDL cholesterol. The beverage comprises from 0.50 w/v% (weight per volume%) to 10 w/v% of total phytosterol and phytostanol equivalents, of which from 5.0% to 25% are in free form and the remainder of these equivalents are in esterified form. The beverage further comprises from 2.0 to 12 w/v% triglyceride fat, at least one additional edible ingredient, and from 60 to 97 w/v% water.

The invention further relates to a package containing at least one drink portion or drink as disclosed above.

The invention further relates to a powder suitable for making a beverage. The powder contains the dry edible ingredients per serving of powder in the beverage according to the invention, or in the same ratio as in the beverage according to the invention.

The present invention still further relates to a method of lowering serum LDL cholesterol in a subject in need thereof, wherein the subject ingests a drink serving or drink as defined above without ingesting a meal.

Detailed Description

Disclosed are improved beverages having a guaranteed serum LDL cholesterol lowering effect. This "assured" serum LDL cholesterol lowering effect means: the serum LDL cholesterol lowering effect obtained when the drink portion or drink according to the invention is consumed without a meal is at least 70% of the serum LDL cholesterol lowering effect of the same amount of total phytosterol and phytostanol equivalents consumed together with a meal. Preferably, the serum LDL cholesterol lowering effect of the drink serving or drink not ingested with the meal is at least 75%, more preferably at least 80%, still more preferably at least 85%, further more preferably at least 90%, even further more preferably at least 95% and most preferably at least 100% of the effect of the same amount of total phytosterol and phytostanol equivalents taken together with the meal. The serum LDL cholesterol lowering efficacy of any daily intake of total phytosterols and/or phytostanol equivalents taken in conjunction with a meal may be calculated based on the dose-response equation disclosed in delmonty et al (journal of nutriology 139(2009) 271-284). Preferably, the assured serum LDL cholesterol lowering effect means: the serum LDL cholesterol lowering effect is maintained regardless of the consumption time of the drink portion or drink relative to the meal ingested.

In this specification, "snack" means an edible product to be ingested between meals (breakfast, lunch or dinner).

The invention relates to a beverage portion with serum LDL cholesterol lowering effect, wherein the beverage portion comprises:

-total phytosterol and phytostanol equivalents from 0.8g to 15g, preferably from 1.0g to 15g, more preferably from 1.5g to 12g, still more preferably from 1.8g to 10g, and most preferably from 2.0g to 8.0g, of which equivalents

a) From 0.10g to 3.0g, preferably from 0.15g to 3.0g, more preferably from 0.18g to 2.5g, still more preferably from 0.20g to 2.0g, and most preferably from 0.20g to 1.5g are in free form, with the proviso that 5.0% to 25%, preferably from 6.0% to 23%, more preferably from 7.0% to 20%, and still more preferably from 8.0% to 18%, and most preferably from 10% to 15% by weight are in free form, and

b) the remainder of these equivalents are in esterified form,

-from 2.5g to 15g, preferably from 3.0g to 12g, more preferably from 4.0g to 12g, still more preferably from 4.5g to 12g, even more preferably from 5.0g to 12g, and most preferably from 6.0g to 12g of triglyceride fat,

-at least one additional edible ingredient, and

-water.

The present invention also relates to a beverage having a serum LDL cholesterol lowering effect, wherein the beverage comprises:

-0.50 to 10 w/v%, preferably 0.80 to 10 w/v%, more preferably 1.0 to 10 w/v%, still more preferably 1.2 to 10 w/v%, even more preferably 1.5 to 10 w/v% and most preferably 2.0 to 10 w/v% of total phytosterol and phytostanol equivalents by weight of these equivalents

a) From 5.0% to 25%, preferably from 6.0% to 23%, more preferably from 7.0% to 20%, and still more preferably from 8.0% to 18%, and most preferably from 10% to 15% are in free form, and

b) the remainder of these equivalents are in esterified form,

-from 2.0 to 12 w/v%, preferably from 3.0 to 12 w/v%, more preferably from 4.0 to 12 w/v%, still more preferably from 4.5 to 12 w/v%, even more preferably from 5.0 to 12 w/v%, and most preferably from 6.0 to 12 w/v% of triglyceride fat,

-0.5 to 37.5 w/v% of at least one additional edible ingredient, and

-60 to 97 w/v% water.

Here, "w/v%" means a percentage by weight per volume (1 w/v% ═ 1g/100 ml).

In this specification, "drink" means: a food product intended for consumption by drinking, i.e. a product which the producer has designed for drinking. Examples of such products are:

milk drinks such as milk, various milk drinks such as shaved ice, milkshakes, yoghurt drinks and drinkable yoghurt (i.e. fermented milk drinks),

non-dairy drinks (meaning milk-substitute drinks made from, for example, soya, rice, oats, almond and/or wheat instead of milk), such as non-dairy milk, non-dairy shaves and drinkable non-dairy yoghurts,

-fruit, berry and/or vegetable drinks,

-coffee, cocoa and/or tea drinks,

-a sports drink, which is,

-opacified soft drinks, and

a healthy drink (which may be any of the previously listed drinks) containing, for example, vitamins, fibres, minerals, probiotics and/or antioxidants.

The purpose of the drink according to the invention is to have a guaranteed serum LDL cholesterol lowering effect also when used as a snack (i.e. without ingestion of a meal). This means that for example one serving can be consumed as a snack drink (i.e. not accompanied by a meal at the same time). Thus, a serving may suitably be consumed at a consumption occasion as defined herein and still give a guaranteed LDL cholesterol lowering effect.

In the present specification, "consumption opportunity" means a time (e.g., from 5 seconds to 30 minutes) for ingestion of a drink or drink portion according to the present invention, as well as a time (e.g., at least 30 minutes) during which no meal is ingested before the start of ingestion of the drink or drink portion, and a time (e.g., at least 30 minutes) during which no meal is ingested after the end of ingestion of the drink or drink portion. Thus, the duration of the consumption opportunity is actually, for example, from 1 hour to 1.5 hours. The benefits obtained from the present invention are: the drink portion or drink can be ingested at such a consumption occasion and still give a guaranteed LDL cholesterol lowering effect.

The serving size of the beverage is suitable for consumption in up to 30 minutes. The serving size of the drink is preferably from 50ml to 500ml, more preferably from 50ml to 400ml, still more preferably from 65ml to 300ml, even more preferably from 100ml to 300ml, and most preferably from 125ml to 300 ml.

Of course, the drink may also be consumed together with a meal (i.e. also immediately before or after) or together with other snack products, but the present invention aims at obtaining a guaranteed serum LDL cholesterol lowering effect for the consumer even when the drink according to the present invention is not consumed together with a meal. Thus, the trader of the beverage can advise consumers that the beverage can be used as a snack. Thus, the beverage according to the present invention can preferably be named a snack beverage.

"drink portion" means: the amount of beverage that is intended to be consumed in one consumption occasion, i.e. the portion of beverage corresponds to one portion of beverage. Preferably, the serving size of the beverage portion according to the invention is 50ml to 500ml, more preferably 50ml to 400ml, still more preferably 65ml to 300ml, even more preferably 100ml to 300ml, and most preferably 125ml to 300 ml.

When used as snacks, the drink portions and drinks according to the invention likewise have a guaranteed serum LDL cholesterol lowering effect. Thus, consumers may be advised to use serving and drink products as snacks. The beverage parts and beverages according to the invention have a serum LDL cholesterol lowering effect of at least 70% when consumed without a meal compared to when the same amount of total phytosterol and phytostanol equivalents are consumed with a meal. Preferably, the drink portion and the drink maintain the LDL cholesterol lowering efficacy regardless of the consumption time of the drink or drink portion relative to the meal ingested. Thus, the drink portion or drink according to the invention is suitable for ingestion at one consumption occasion as defined herein. Most preferably, the beverage is a snack and the beverage serving is a snack.

The term "edible ingredient" here means all components of the drink or drink portion, such as phytosterols and/or phytosterols, triglyceride fat, water and further edible ingredients.

In this specification, phytosterols include and are preferably 4-desmethyl sterols and 4-monomethyl sterols, and phytostanols include and are preferably 4-desmethyl sterols and 4-monomethyl sterols. Typical 4-demethylsterols are sitosterol, campesterol, stigmasterol, brassicasterol, 22-dehydro-brassicasterol and 5-avenasterol. Typical stanols are sitostanol, campestanol and the 24-epimer thereof. The term "phytosterols and/or phytostanols" includes all possible mixtures of sterols and/or stanols as well as any individual phytosterols and/or phytostanols.

The phytosterols and/or phytostanols used in the present invention comprise phytosterols and/or phytostanols in both free and esterified form. Phytosterols and/or phytosterols in esterified form are esterified with a carboxylic acid or with a mixture of carboxylic acids. Examples of suitable carboxylic acids are fatty acids (having 2 to 24 carbon atoms, being saturated, mono-or polyunsaturated, also including special fatty acids (such as EPA and DHA) and conjugated fatty acids (e.g. CLA)). Preferably, these phytosterols and/or phytosterol alcohols are esterified with fatty acids, most preferably with vegetable oil based fatty acids.

Plant stanol fatty acid esters and their use and suitable methods for their preparation are disclosed in US 6174560. Obviously, phytosterol esters may also be efficiently produced by the production method disclosed in US 6174560. Alternatively, fatty acid esters of phytosterols and/or phytosterols may be produced by any of the methods disclosed in the art.

By "phytosterol equivalent" is meant the amount of phytosterols calculated as the amount of free phytosterols. This means that in the case of phytosterol esters, only the phytosterol part of the molecule is calculated as a phytosterol equivalent and the acid part is ignored.

Correspondingly, "phytostanol equivalent" means the amount of phytosterols calculated as the amount of free phytosterols. This means that in the case of a phytostanol ester, only the phytostanol part of the molecule is calculated as a phytostanol equivalent and the acid part is omitted.

Thus, "total phytosterol and phytostanol equivalents" means the total amount of phytosterol equivalents and phytostanol equivalents. Thus, "total phytosterol and phytostanol equivalents" include phytosterols and phytosterols in both free and esterified forms, however expressed as the total amount of free phytosterols and free phytosterols. Thus, these equivalents may contain only phytosterols or mixtures thereof.

Of the total phytosterol and phytostanol equivalents, 5.0% to 25% by weight, preferably 6.0% to 23% by weight, more preferably 7.0% to 20% by weight, still more preferably 8.0% to 18% by weight, and most preferably 10% to 15% by weight are in the free form, and the remainder of these equivalents are in the esterified form.

The phytosterol and/or phytostanol composition used in the present invention may be obtained by stopping the esterification reaction when the desired degree of esterification has been reached. Alternatively, to prepare these phytosterols and/or phytostanols, a suitable amount of free phytosterols and/or free phytostanols may be added to the phytosterol and/or phytostanol esters which have been prepared, for example, using any conventional esterification method which can obtain a high degree of esterification (typically at least 97% by weight).

The phytosterols and/or phytostanols may be incorporated into the beverage or beverage portion during the preparation of the beverage or beverage portion, under any suitable manufacturing step. These free phytosterols and/or phytostanols and these esterified phytosterols and/or phytostanols may also be added separately under any suitable production steps. In such cases, the composition of phytosterols and/or phytosterols is formed at the latest within the final beverage or beverage portion.

Most preferred in the drink or drink portion according to the invention is a composition of phytosterols and/or phytostanols wherein from 50% to 100% (by weight) of the total phytosterols and phytostanol equivalents in the composition are phytostanol equivalents. Preferably, there is at least 70%, more preferably at least 80%, still more preferably at least 90%, and most preferably at least 95% by weight of the total phytosterol and phytostanol equivalents.

Also preferred in the drink or drink portion according to the invention is a composition of phytosterols and/or phytosterols wherein 50% to 100% (by weight) of the phytosterols and/or phytosterols in free form are phytosterols. Preferably, at least 70%, more preferably at least 80%, still more preferably at least 90%, and most preferably at least 95% by weight of the total amount of free phytosterols and free phytosterol alcohols is free phytosterols. However, it is also possible to have a composition in which 50 to 100% by weight of the free phytosterols and/or phytostanols are free phytostanols.

The drink portion according to the invention contains phytosterols and/or phytosterols in the following amounts:

-total phytosterol and phytostanol equivalents from 0.8g to 15g, preferably from 1.0g to 15g, more preferably from 1.5g to 12g, still more preferably from 1.8g to 10g, and most preferably from 2.0g to 8.0g, of which equivalents

a) From 0.10g to 3.0g, preferably from 0.15g to 3.0g, more preferably from 0.18g to 2.5g, still more preferably from 0.20g to 2.0g, and most preferably from 0.20g to 1.5g are in free form, with the proviso that 5.0% to 25%, preferably from 6.0% to 23%, more preferably from 7.0% to 20%, and still more preferably from 8.0% to 18%, and most preferably from 10% to 15% by weight are in free form, and

b) the remainder of these equivalents are in esterified form.

The drink according to the invention contains phytosterols and/or phytosterols in the following amounts:

-0.50 to 10 w/v%, preferably 0.80 to 10 w/v%, more preferably 1.0 to 10 w/v%, still more preferably 1.2 to 10 w/v%, even more preferably 1.5 to 10 w/v% and most preferably 2.0 to 10 w/v% of total phytosterol and phytostanol equivalents, in which equivalents

a) From 5.0% to 25%, preferably from 6.0% to 23%, more preferably from 7.0% to 20%, and still more preferably from 8.0% to 18%, and most preferably from 10% to 15% are in free form, and

b) the remainder of these equivalents are in esterified form.

As used herein, "triglyceride fats" means edible fats and oils consisting predominantly (at least 90%, preferably at least 95% and most preferably at least 98% by weight) of triacylglycerols. The triglyceride fat may be an inherent part of the drink portion and drink (i.e., the triglyceride fat of soybean oil in a soybean-based drink, or the dairy triglyceride fat in a milk-based drink) or the triglyceride fat may be added separately to the drink portion or drink. The triglyceride fat may also be a mixture of different edible fats and/or oils. Typical examples of triglyceride fats are vegetable oils such as canola oil/seed oil, soybean oil, sunflower oil, olive oil, corn oil, sesame oil, cottonseed oil, wheat germ oil, oat oil, linseed oil, peanut oil, cabbage oil (camelliaoil) and triglyceride fats of dairy and fish origin. These triglyceride fats may be naturally occurring or modified (e.g., hydrogenated, transesterified) or contain structured triacylglycerols. Preferably, these triglyceride fats are vegetable oils, most preferably vegetable oils containing omega-3 fatty acids. Preferably, the amount of saturated fatty acids in the triglyceride fat is less than 35% of the total fatty acids, more preferably less than 30%, still more preferably less than 25%, and most preferably less than 20% of the total fatty acids. Preferably, at least part of the triglyceride fat is an inherent part of the drink portion and drink.

The beverage according to the invention contains from 2.0% to 12%, preferably from 3.0% to 12%, more preferably from 4.0% to 12%, still more preferably from 4.5% to 12%, even more preferably from 5.0% to 12%, and most preferably from 6.0% to 12% triglyceride fat by weight per volume.

The drink portion according to the invention contains from 2.5g to 15g, preferably from 3.0g to 12g, more preferably from 4.0g to 12g, still more preferably from 4.5g to 12g, even more preferably from 5.0g to 12g, and most preferably from 6.0g to 12g of triglyceride fat.

The drink portions and drinks according to the invention also contain at least one additional (i.e. another) edible ingredient, such as an emulsifier, a stabilizer, a protein, a sweetener, a flavoring agent, a coloring agent, a preservative, and an ingredient with a beneficial health effect, or a mixture of additional edible ingredients. The amount of the one or more additional comestible ingredients in the beverage according to the invention is preferably from 0.5 to 37.5 w/v%. The additional edible ingredient may be an inherent part of the drink portion or drink (e.g., protein in a soy or dairy based drink) and/or the additional edible ingredient may be added separately to the drink portion or drink.

Herein, the term "emulsifier" means a substance that promotes the formation of an emulsion. Non-limiting examples of suitable emulsifiers that can be used in the present invention are: mono-and diglyceride derivatives, such as acetate, lactate, succinate or citrate; sorbitan esters; a polysorbate; stearoyl lactylates such as sodium stearoyl lactylate and calcium stearoyl lactylate; diacetyl tartaric acid esters; diacetyl lactic acid esters; sugar esters; lecithin and its derivatives; and mixtures of any of these. Preferred emulsifiers are citric acid esters of mono-and diglycerides, lactic acid esters of mono-and diglycerides, diacetyltartaric acid esters of mono-and diglycerides, polysorbates, sodium stearoyl lactylate, calcium stearoyl lactylate, sucrose fatty acid esters and mixtures of any of these. The most preferred emulsifiers for use in the present invention are citric, lactic and diacetyltartaric esters of mono-and diglycerides; polysorbates, and mixtures of any of these. The amount of emulsifier (if any) used in the drink portions and drinks according to the invention is typically from 0.05 to 0.50% by weight, and more typically from 0.10 to 0.40% by weight per volume of the drink portion and drink.

Herein, the term "stabilizer" means a substance that promotes the stability of the drink portion and drink. Suitable examples include: hydrocolloids such as pectin, carrageenan; starches and modified starches; maltodextrins; alginates; gums such as xanthan gum, guar gum, locust bean, tragacanth gum, acacia gum and gellan gum (gellan); and mixtures thereof. Suitable amounts of the different stabilizers to be used are clear to the skilled person in order to obtain a commercially acceptable drink portion and drink.

The drink portions and drinks of the present invention may contain protein. Examples of suitable proteins include: milk proteins such as casein and whey proteins; soy protein; various cereal proteins, such as wheat or rice proteins, pea proteins, lupin proteins, canola proteins and mixtures of any of these. Protein may be an inherent part of the serving and beverage (i.e., soy protein in a soy-based beverage or dairy protein in a milk-based beverage) or may be added separately to the serving and beverage, for example, as flour containing protein, protein concentrate, or protein isolate. Preferably, the drink portions and drinks contain non-dairy proteins.

The protein content of the beverage is preferably from 1.0% to 12% by weight per volume of the beverage, more preferably 3.0% to 11% by weight per volume of the beverage, still more preferably 4.0% to 11%, even more preferably 5.0% to 11%, further more preferably 6.0% to 11%, and most preferably 6.0% to 9.0%. This protein content is suitable for any serving of the beverage according to the invention (50ml to 500 ml).

The drink portion according to the invention may contain from 1.0g to 35g, preferably from 2.0g to 33g, more preferably from 3.0g to 30g, still more preferably from 4.0g to 28g of protein. Typically, there is at least 6.0g, more typically at least 8.0g, still more typically at least 10g, even more typically at least 12g, and most typically at least 14g of protein per serving.

Preferably, the drink portions and drinks according to the invention contain no lactose or only low levels of lactose. Here, a low level of lactose means that the beverage has at most 1g of lactose per 100ml of beverage. Non-dairy drinks such as soy, oat and rice based drinks are naturally lactose free and are therefore well suited for use in the present invention. Also suitable are milk based drinks with low levels of lactose or those without lactose. However, milk drinks containing natural or increased levels of lactose are also suitable alternatives.

The drink portions and drinks according to the present invention may contain various sweeteners and flavoring agents. As used herein, the term "sweetener" includes compounds that are used to increase the sweetness of a product. Non-limiting examples of such compounds are e.g. sucrose and other sugars; syrups; honey; sugar alcohols such as xylitol, maltitol, lactitol, sorbitol, and erythritol (erythrol); non-carbohydrate sweeteners such as aspartame, acesulfame-K, saccharin, cyclamates, sucralose, and stevia. As used herein, the term "flavoring agent" means an ingredient that imparts flavor to the beverage portion and beverage. Examples of such flavoring agents include various plant extracts; fragrances, such as vanilla; cocoa powder; coffee; tea; and products from berries, fruits and/or vegetables, if puree, jelly, juice, puree, juice concentrate; and the berries and/or fruit themselves (e.g., fresh, frozen or dried).

Non-limiting examples of ingredients with beneficial health effects are vitamins (e.g., vitamin C, vitamin D, vitamin E, and vitamin K), minerals, fibers, antioxidants, polyphenols, and probiotics.

The drink portions and drinks according to the invention also contain water. The term "water" also includes water naturally present in the beverage portion or any edible ingredient of the beverage, such as the water content of milk or a fruit preparation. The water content of the drink portions and drinks according to the invention is typically 60% to 97%, preferably at least 65%, more preferably at least 70%, and most preferably at least 75% by weight per volume. This water content applies to any serving size (50ml to 500ml) of the beverage according to the invention.

The drink portion and drink according to the present invention is an oil-in-water (O/W) type emulsion. In the present specification, "oil-in-water (O/W) type emulsion" means an emulsion in which oil exists as a dispersed phase and water exists as a continuous phase. The drink portion and drink of the present invention may be an acid stable O/W emulsion. Here, the acid-stable emulsion means an O/W type emulsion which is stable under acidic conditions (i.e., the oil/fat phase and the aqueous phase are not separated despite the low pH). By acid stable emulsion is especially meant an emulsion that retains its structure at a pH value typically of 5.0, 4.5, 4.0, 3.5, 3.0, or even 2.5. The structure can be measured by evaluating the droplet (or particle) size distribution of the emulsion by known techniques, such as by light scattering techniques. The droplet size distribution of the emulsion remains the same or there is only a slight change in the droplet size distribution when the emulsion is exposed to acidic conditions as compared to the original droplet size distribution of the emulsion.

The structural properties of these drink emulsions change when they are ingested into the mouth and gastrointestinal tract. These emulsions are subjected to very low pH, mechanical agitation, and digestive juices in the stomach. In the human stomach, the pH is typically 1 to 3. An acid stable emulsion preferably means an emulsion that retains its structure at the pH values typical of the human stomach.

The carbohydrate content of the drink portion and drink is 0 w/v% to 25 w/v% (g/100ml) and is preferably present in at least 1.0 w/v%, more preferably at least 2.0 w/v%, still more preferably at least 4.0 w/v%, even more preferably at least 6.0 w/v%, and most preferably at least 8.0 w/v%. This carbohydrate content applies to any serving size (50ml to 500ml) of the beverage according to the invention.

The energy content of the drink portions and drinks according to the invention is preferably at least 250kJ/100ml, more preferably at least 300kJ/100ml, still more preferably at least 350kJ/100ml, even more preferably at least 400kJ/100ml, further more preferably at least 450kJ/100ml, still further more preferably at least 500kJ/100ml and most preferably at least 550kJ/100 ml. The energy content of the drink portions and drinks is preferably at most 1300kJ/100ml, more preferably at most 1000kJ/100ml, still more preferably at most 800kJ/100ml, and most preferably at most 700kJ/100 ml. These energy contents apply to any serving size (50ml to 500ml) of the beverage according to the invention.

The invention further relates to a package containing a drink or at least one drink portion having a serum LDL cholesterol lowering effect as disclosed above.

Here, "packaging" means the physical protection that the beverage or at least one beverage portion is enclosed within. The package may be, for example, a plastic bottle or any container suitable for liquid food products. The package may contain one or more serving beverages, but most preferably the package contains one serving beverage.

Preferably, the size of the package is from 50ml to 25l, more preferably from 50ml to 1.5l, still more preferably from 50ml to 1l, even more preferably from 50ml to 500ml, still even more preferably from 50ml to 400ml, still more preferably from 65ml to 300ml, still further preferably from 100ml to 300ml, and most preferably from 125ml to 300 ml.

Preferably, the serving of the drink portion in the package according to the invention is 50 to 500ml, more preferably 50 to 400ml, even more preferably 65 to 300ml, still more preferably 100 to 300ml, and most preferably 125 to 300 ml.

According to the invention, the package preferably contains one serving of beverage.

The package may further deliver the following recommendations to the consumer: when the drink portion is used as a snack, the drink portion also has a secured serum LDL cholesterol lowering effect. This means that the beverage serving has a serum LDL cholesterol lowering effect of at least 70% when not consumed with a meal compared to when the same amount of total phytosterol and phytostanol equivalents are consumed with a meal. The drink portion preferably maintains the LDL cholesterol lowering efficacy regardless of its consumption time relative to ingestion of a meal. Most preferably, the package according to the present invention may deliver the following recommendations to the consumer: the beverage can be used as a snack.

According to a preferred embodiment of the invention, the beverage has a serving size of from 200ml to 300ml and comprises:

-from 0.50 to 7.5 w/v%, preferably from 0.80 to 6.0 w/v%, more preferably from 1.0 to 5.0 w/v%, and most preferably from 1.2 to 4.0 w/v% of total phytosterol and phytostanol equivalents, among these equivalents

a) From 5.0% to 25%, preferably from 6.0% to 23%, more preferably from 7.0% to 20%, and still more preferably from 8.0% to 18%, and most preferably from 10% to 15% are in free form, and

b) the remainder of these equivalents are in esterified form,

-from 2.0 to 7.5 w/v%, preferably from 2.5 to 7.0 w/v%, more preferably from 3.0 to 6.5 w/v%, and most preferably from 4.0 to 6.0 w/v% of triglyceride fat,

-0.5 to 37.5 w/v% of at least one additional edible ingredient, and

-60 to 97 w/v% water.

According to a second preferred embodiment of the invention, the beverage has a serving size of from more than 125ml to less than 200ml (such as from 126ml to 199ml) and comprises:

-from 0.50 to 10 w/v%, preferably from 1.0 to 10 w/v%, more preferably from 1.2 to 8.0 w/v%, most preferably from 1.5 to 6.0 w/v% of total phytosterol and phytostanol equivalents, among these equivalents

a) 5.0% to 25%, preferably 6.0% to 23%, more preferably 7.0% to 20%, and still more preferably 8.0% to 18%, and most preferably 10% to 15% are in free form, and

b) the remainder of these equivalents are in esterified form,

-from 2.0 to 12 w/v%, preferably from 2.5 to 10 w/v%, more preferably from 3.0 to 8.0 w/v%, and most preferably from 4.0 to 6.0 w/v% of triglyceride fat,

-0.5 to 37.5 w/v% of at least one additional edible ingredient, and

-60 to 97 w/v% water.

According to a third preferred embodiment of the invention, the beverage has a serving size of from 65ml to 125ml and comprises:

-total phytosterol and phytostanol equivalents from 0.80 to 10 w/v%, preferably from 1.0 to 10 w/v%, more preferably from 1.5 to 10 w/v% and most preferably from 2.0 to 8.0 w/v%, among these equivalents

a) From 5.0% to 25%, preferably from 6.0% to 23%, more preferably from 7.0% to 20%, and still more preferably from 8.0% to 18%, and most preferably from 10% to 15% are in free form, and

b) the remainder of these equivalents are in esterified form,

-from 2.0 to 12 w/v%, preferably from 3.0 to 12 w/v%, more preferably from 4.0 to 10 w/v%, most preferably from 5.0 to 8.0 w/v% of triglyceride fat,

-0.5 to 37.2 w/v% of at least one additional edible ingredient, and

-60 to 97 w/v% water.

For the three embodiments, the one or more additional comestible ingredients of the beverage are as previously disclosed herein. A package suitable for use in the three preferred embodiments is as previously disclosed herein and, furthermore, the size of the package is still more preferably from 200ml to 300ml, from greater than 125ml to less than 200ml, and from 65ml to 125ml, respectively.

The invention further relates to a powder suitable for making a beverage. The powder contains, preferably consists of: the dry edible ingredients per serving of powder serving of the beverage according to the invention, or the same ratio as in the beverage according to the invention (i.e. the dry edible ingredients are in the same amount relative to each other as in the beverage according to the invention).

Such a drink powder contains the drink portion or the dry ingredients of the drink. The drink powder may be prepared by drying the drink portion or the drink by any suitable drying technique, such as spray drying. In the case of spray drying, it is advantageous to have protein and/or maltodextrin as one of the one or more additional edible ingredients in the beverage serving or the beverage. To reconstitute the drink portion or the drink, the drink powder is mixed with a liquid (such as, for example, water). It is also possible to reconstitute the drink portion or the drink by mixing the drink powder with some liquid other than the liquid that was originally removed by drying. For example, a milk drink serving or drink may be dried to form a drink powder, which may be added, for example, to coffee to reconstitute the drink serving or composition of the drink.

The invention further relates to a method of lowering serum LDL cholesterol in a subject in need thereof, wherein the subject ingests a drink or drink portion according to the invention without ingesting a meal. This means that the method of lowering LDL cholesterol is improved in this way: the drink or drink portion can be consumed without the concurrent ingestion of a meal. This means that the serving or beverage can be ingested as a snack drink (i.e., without a meal while being consumed). Thus, the method enables an assured reduction of serum LDL cholesterol at the same moment of consumption, without ingestion of a meal, for example within 30 minutes before starting consumption of the drink or drink portion and within 30 minutes after finishing consumption of the drink or drink portion. The purpose of the method is that the subject obtains a guaranteed serum LDL cholesterol lowering effect even when the drink or drink portion according to the present invention is not used with a meal.

Example 1 (comparative example)

Two kinds of drinks were prepared. The formulations of these drinks are presented in table 1. Both drinks contained 2.0g phytostanol equivalent per 100ml of drink. In drink 1, 10% (0.2g) of the phytostanol equivalents were free phytosterols and 90% (1.8g) were fatty acid esterified phytosterols. The reference drink (C700) contained commercial phytostanol esters, wherein the phytosterols were esterified with rapeseed oil fatty acids. (classic C700, Raisio Nutrition Ltd.).

Table 1.

These dry ingredients and water were mixed into the soymilk and warmed up to 60 ℃. After that, the phytostanol composition or the phytostanol ester classic c700 and emulsifier are mixed together and then added to the warmed mixture. The mixture obtained was UHT treated (145 ℃, 3 to 5s), homogenized (200 bar, 60 ℃) and packaged.

The content of triglyceride fats, total phytosterol and phytostanol equivalents, and free phytosterols and phytosterol alcohols are presented in table 2. The total phytosterol and phytostanol equivalents were analyzed by saponifying the sample with an alcoholic solution of potassium hydroxide, extracting the unsaponifiable matter with hexane, and analyzing the silyl ether derivatives by a gas chromatography. Free phytosterols and phytosterol alcohols were analyzed by using solid phase extraction and gas chromatography analysis. The amount of phytosterols and phytostanol equivalents in esterified form is calculated by subtracting the amount of free phytosterols and phytostanols from the amount of total phytosterols and phytostanol equivalents. The amount of plant sterol ester and plant stanol ester is calculated by multiplying the amount of plant sterol and plant stanol equivalent in esterified form by 1.67. The crude fat content was analyzed by acid hydrolysis and by caramel (B ü chi) extraction. The amount of free phytosterols and phytostanols and the amount of phytosterol esters and phytostanol esters are subtracted from the crude fat content to obtain the triglyceride fat content.

Table 2.

Comprising both esterified and free phytostanols

The cholesterol lowering efficacy of these drinks was studied in subjects with mild hypercholesterolemia (n ═ 35 persons/group). These subjects consumed either drink 1(100ml) or drink C700(100ml) separately from the meal in the morning, a minimum of 30min before breakfast for 3 weeks. No other beverage like coffee or tea is allowed within 30 minutes from taking these drinks. The study subjects were asked to keep the intake time of the study drink constant throughout the intervention. In other aspects, the subjects follow their dietary habits. Blood samples were taken after an overnight fast of 10h to 12h before starting consumption of the drink and after 3 weeks of consumption of the drink. Serum total cholesterol, HDL cholesterol and triglycerides were analyzed enzymatically and LDL cholesterol was calculated using the Friedewald formula (the main outcome of this study).

The results of this clinical study are presented in table 3. The LDL cholesterol lowering efficacy of this beverage 1 was compared to that obtained using beverage C700 and also compared to the prior art study of dounbus (Doornbos) et al (2005). The study design in the dunnbus study was comparable, i.e. a low volume (100ml) yoghurt drink containing phytosterol esters was taken on an empty stomach 1/2 hours before breakfast. The triglyceride fat content (1.5g of dairy fat) of dunnbus beverage B was comparable to that of beverage 1, but the phytosterol content (2.8g total phytosterols and phytostanol equivalents) was higher than that of beverage 1. Since there were no placebo drinks taken with no meals in the dunnbus study, the reduction of LDL cholesterol from baseline levels was used for comparative purposes.

Table 3.

LDL cholesterol was only 2.7% lower from baseline in these subjects consuming beverage 1 with no meal on an empty stomach 1/2 hours before breakfast. This LDL cholesterol lowering efficacy was comparable to that obtained using drink C700 and drink B in the study of durinbus et al (2005). Thus, increasing the amount of free phytosterols does not improve the LDL cholesterol lowering efficacy.

Example 2

Two beverages (beverage 2 and beverage 3) were prepared. The formulations of these drinks are presented in table 4. Both drinks contained 2.0g phytostanol equivalent per 100ml of drink and increased levels of triglyceride fat (6.0g triglyceride fat, from soy milk and rapeseed oil) compared to the drink of example 1. Drink 2 contained commercial plant stanol ester ClassicC 700. Drink 3 contained 2.0g of phytostanol equivalents, of which 10% (0.2g) were free phytosterols and 90% (1.8g) were fatty acid esterified phytosterols.

TABLE 4

Drinks 2 and 3 were prepared and analyzed in a similar manner to the drink in example 1. The triglyceride fat, total phytosterol and phytostanol equivalents, and the content of free phytosterols and phytosterol alcohols for drink 2 and drink 3 are presented in table 5.

TABLE 5

Comprising both esterified and free phytostanols

The cholesterol lowering efficacy of beverage 2 and beverage 3 was studied in the same way as the efficacy of the beverage in example 1. The results are presented in table 6.

Table 6.

Increasing the amount of triglyceride fat (drink 2) did not improve LDL cholesterol lowering efficacy compared to drink C700 of example 1. LDL cholesterol was only reduced by 3.4% from baseline in these subjects who consumed drink 2 with no meal on an empty stomach 1/2 hours before breakfast. However, it has surprisingly been found that: increasing both the triglyceride fat content and the free phytosterol content (drink 3) achieved good LDL cholesterol lowering efficacy even when these drinks were consumed in the fasted state. LDL cholesterol was reduced by 7.2% from baseline levels in these subjects consuming beverage 3 without meal on an empty stomach 1/2 hours before breakfast. Thus, the LDL cholesterol lowering efficacy has the same magnitude as can be achieved when consuming a drink containing about 2g phytosterols and/or phytostanols together with a meal.

Example 3

A drinkable yoghurt-type drink having the following ingredients was prepared.

Of these total phytosterol and phytostanol equivalents, 85% are esterified phytosterols and 15% are free phytosterols and phytosterols. Of these total phytosterol and phytostanol equivalents, 53% are phytostanols and 47% are phytosterols. Of these free phytosterols and phytostanols, 53% are phytostanols and 47% are phytosterols.

The beverage has a weight of 150 ml. One part contained 4.5g triglyceride fat (dairy fat) and 3g total phytosterol and phytostanol equivalents, of which 0.45g was in free form.

Example 4

A beverage containing soy protein isolate is prepared having the following ingredients.

Of these phytostanol equivalents, 90% are esterified and 10% are free phytosterols.

The drink contains per 100ml serving size 6g triglyceride fat (rapeseed oil) and 3g phytostanol equivalent, of which 0.3g is in free form. The protein content of the beverage is 6g/100 ml.

Example 5

An oat-based beverage having the following ingredients was prepared.

Of these phytostanol equivalents, 90% are esterified and 10% are free phytosterols

The drink was packaged in 250ml portions. One serving (250ml) contained 6.2g triglyceride fat (cabbage mustard seed oil and triglyceride fat from oat milk) and 3.1g phytostanol equivalent, of which 0.3g was in free form. The protein content was 1.6 g/serving.

Example 6

A milk-based drink having the following ingredients was prepared.

Of these phytostanol equivalents, 82% are esterified and 18% are free phytosterols.

The drink was packaged in 60ml portions. One portion (60ml) contained 3.5g triglyceride fat and 1.5g phytostanol equivalent, of which 0.3g was in free form.

Example 7

A juice-based drink having the following ingredients was prepared.

Of these phytostanol equivalents, 90% are esterified and 10% are free phytosterols.

The beverage was packaged into 500ml bottles containing two servings per bottle. One serving (250ml) contained 6.25g triglyceride fat and 2.5g phytostanol equivalent, of which 0.2g was in free form.

Claims (37)

1. A drink serving having a serum LDL cholesterol lowering effect, wherein the drink serving comprises:

-total phytosterol and phytostanol equivalents from 0.8g to 15g, of which

a) From 0.10g to 3.0g is in free form, with the proviso that from 5.0% to 25% by weight is in free form, and

b) the remainder of these equivalents are in esterified form,

-from 2.5g to 15g of triglyceride fat,

-at least one additional edible ingredient, and

-water.

2. The beverage portion according to claim 1 wherein the amount of total phytosterol and phytostanol equivalents is from 1.5 to 12 g.

3. Serving according to claim 1, wherein the amount of equivalents in free form is from 0.18 to 2.5 g.

4. Serving of drink according to claim 1, wherein 7.0 to 20% by weight of equivalents are in free form.

5. Serving of drink according to claim 1, wherein the amount of triglyceride fat is from 4.5g to 12 g.

6. Serving of drink according to claim 1, wherein the amount of triglyceride fat is from 6.0g to 12 g.

7. The serving of claim 1, wherein the serving comprises:

-1.5g to 12g total phytosterol and phytostanol equivalents, of which

a) From 0.18g to 2.5g are in free form, with the proviso that 7.0% to 20% by weight are in free form, and

b) the remainder of these equivalents being in esterified form, an

-4.5g to 12g triglyceride fats.

8. Serving of drink according to claim 7, wherein the amount of triglyceride fat is from 6.0g to 12 g.

9. The serving of claim 1, wherein the serving comprises:

-2.0g to 8.0g total phytosterol and phytostanol equivalents, of which

a) From 0.20g to 1.5g are in free form, with the proviso that from 10% to 15% by weight are in free form, and

b) the remainder of these equivalents being in esterified form, an

-6.0g to 12g triglyceride fats.

10. Serving according to claim 1, wherein the at least one further edible ingredient of the serving comprises protein in an amount of 1.0 to 35 g.

11. Serving according to claim 1, wherein the at least one further edible ingredient of the serving comprises protein in an amount of 4.0 to 28 g.

12. Serving according to claim 7, wherein the at least one further edible ingredient of the serving comprises protein in an amount of 4.0 to 28 g.

13. Serving according to claim 8, wherein the at least one further edible ingredient of the serving comprises protein in an amount of 4.0 to 28 g.

14. Serving according to claim 9, wherein the at least one further edible ingredient of the serving comprises protein in an amount of 4.0 to 28 g.

15. Serving according to claim 9, wherein the at least one further edible ingredient of the serving comprises protein in an amount of at least 6.0 g.

16. A beverage having a serum LDL cholesterol lowering effect, wherein the beverage comprises:

-from 0.50 to 10 w/v% total phytosterol and phytostanol equivalents, of which

a) 5.0% to 25% are in free form, and

b) the remainder of these equivalents are in esterified form,

-from 2.0 w/v% to 12 w/v% triglyceride fat,

-0.5 to 37.5 w/v% of at least one additional edible ingredient, and

-60 to 97 w/v% water.

17. The beverage according to claim 16, wherein 7.0% to 20% of the equivalents are in free form.

18. The beverage according to claim 16, wherein the amount of triglyceride fat is from 4.5 to 12 w/v%.

19. The beverage according to claim 17, wherein the amount of triglyceride fat is from 6.0 to 12 w/v%.

20. The beverage according to claim 16, wherein the beverage comprises:

-2.0 to 10 w/v% total phytosterol and phytostanol equivalents, of which

a) 10% to 15% are in free form, and

b) the remainder of these equivalents being in esterified form, an

-6.0 to 12 w/v% triglyceride fat.

21. The beverage according to claim 18, wherein the at least one additional edible ingredient of the beverage comprises protein in an amount of 1.0 to 12 w/v% of the beverage.

22. The beverage according to claim 18, wherein the at least one additional edible ingredient of the beverage comprises protein in an amount of 6.0 to 9.0 w/v% of the beverage.

23. The beverage according to claim 20, wherein the at least one additional edible ingredient of the beverage comprises protein in an amount of 1.0 to 12 w/v% of the beverage.

24. The beverage according to claim 20, wherein the at least one additional edible ingredient of the beverage comprises protein in an amount of 6.0 to 9.0 w/v% of the beverage.

25. A package containing a beverage according to any one of claims 16-24, or at least one portion of a beverage according to any one of claims 1-15.

26. The package according to claim 25, wherein the package contains a serving of a beverage.

27. The beverage portion according to any one of claims 1-15, the beverage according to any one of claims 16-24, or the package according to claim 25 or 26, wherein the beverage or beverage portion has an assured serum LDL cholesterol lowering effect when used as a snack.

28. The drink portion according to any one of claims 1-15, the drink according to any one of claims 16-24, or the package according to claim 25 or 26, wherein it is advised that the consumer can use the drink or drink portion as a snack.

29. The beverage serving according to any one of claims 1-15, the beverage according to any one of claims 16-24, or the package according to claim 25 or 26, wherein the beverage or beverage serving has at least a 70% reduction in serum LDL cholesterol when not consumed with a meal compared to when the same amount of total phytosterol and phytostanol equivalents are consumed with a meal.

30. The beverage serving according to any one of claims 1-15, the beverage according to any one of claims 16-24, or the package according to claim 25 or 26, wherein the beverage or beverage serving maintains the serum LDL cholesterol lowering efficacy regardless of the beverage or beverage serving's consumption time relative to ingestion of a meal.

31. The beverage serving according to any one of claims 1-15, the beverage according to any one of claims 16-24, or the package according to claim 25 or 26, wherein the beverage or beverage serving is a snack.

32. Beverage portion according to any one of claims 1-15, beverage according to any one of claims 16-24, or package according to claim 25 or 26, wherein the beverage or beverage portion is in an amount of 50ml to 500 ml.

33. Serving of a beverage according to any one of claims 1 to 15, a beverage according to any one of claims 16 to 24, or a package according to claim 25 or 26, wherein the serving size of the beverage or serving is 125ml to 300 ml.

34. The beverage portion according to any one of claims 1-15, the beverage according to any one of claims 16-24, or the package according to claim 25 or 26, wherein the energy content of the beverage or beverage portion is at least 250kJ/100ml and at most 1300kJ/100 ml.

35. The beverage portion according to any one of claims 1-15, the beverage according to any one of claims 16-24, or the package according to claim 25 or 26, wherein the energy content of the beverage or beverage portion is at least 450kJ/100ml and at most 1300kJ/100 ml.

36. A powder suitable for use in making a beverage, wherein the powder contains the same proportion of dry ingredients per serving of the beverage according to any one of claims 1-15, 27-35, or the beverage according to any one of claims 16-24, 27-35.

37. Use of a beverage or beverage serving according to any one of the preceding claims or as defined in any one of the preceding claims for the preparation of a food product for lowering serum LDL cholesterol in a subject in need thereof, wherein said food product is not ingested by the subject with a meal.