WO2009144268A1

WO2009144268A1 - Composition for increasing gastrointestinal transit time

Info

Publication number: WO2009144268A1
Application number: PCT/EP2009/056523
Authority: WO
Inventors: Annika Viberg; Bengt Herslöf
Original assignee: Dsm Ip Assets B.V.
Priority date: 2008-05-30
Filing date: 2009-05-28
Publication date: 2009-12-03

Abstract

Use of a mixture comprising a triglyceride oil and an emulsifier for increasing the transit time of a foodstuff through the gastro-intestinal tract of an individual, which foodstuff is consumed concomitantly with or subsequent to administration of the mixture.

Description

COMPOSITION FOR INCREASING GASTROINTESTINAL TRANSIT TIME

Field of the invention

This invention is in the field of weight management. Accordingly, the invention relates to a composition for increasing the gastro-intestinal transit time of a foodstuff.

Background of the invention

The increasing incidence of obesity is a recognized medical problem in developed countries. Obesity is a major factor for a number of diseases, including coronary heart diseases, hypertension, non-insulin dependent diabetes mellitus, pulmonary dysfunction, osteoarthritis and certain types of cancer. Obesity develops when the equilibrium between energy intake and energy expenditure shifts towards a positive energy balance. Even modest weight loss, 5 to 10% of the initial body-weight is considered medically interesting.

Obesity can be classified as a mild (20-30% overweight), moderate (30-60% overweight) or a severe (> 60% overweight) condition. Obesity is accompanied by a number of health hazards. It may impair both cardiac and pulmonary functions, perturb endocrine functions and cause emotional problems. Hypertension, impaired glucose tolerance and non-insulin dependant diabetes mellitus and hypercholesterolemia are more common conditions in overweight individuals than in individuals of normal weight. Obesity may therefore contribute to morbidity and mortality in individuals suffering from e.g. hypertension, stroke, diabetes mellitus type II, some types of cancer, gallbladder disease and ischaemic heart disease. Moderate and severe cases of obesity are known to increase mortality. Colon and rectal cancer are diseases which frequently appear in obese men, and obese women often suffer from endometrium or gallbladder cancer. Furthermore, it is realized that an increase in overweight almost consequently leads to a rise in psychological and social problems.

It is known that the digestion and absorption of certain food types in the distal sections of the small intestine may stimulate a feedback signal associated with the slowing of gastrointestinal transit and the release of satiety hormones. Accordingly, a product which can slow gastrointestinal transit time may be useful in inducing satiety.

Summary of the invention

The inventors have studied the effects of a mixture of a triglyceride oil, which triglyceride oil optionally has a solid fat content at ambient to body temperature, and an emulsifier, preferably a food emulsifier, on gastro-intestinal transit time of a subsequently consumed meal. Individuals consumed the mixture and, subsequently, consumed a meal which contained a marker which is degraded in the caecum to a metabolite which could be detected in the blood. The metabolite was observed in the blood of Individuals who consumed the mixture later after consumption of the marker than in individuals who had not consumed the mixture. Accordingly, the mixture may be used to increase (i.e. slow) gastro- intestinal transit time. This can help to induce satiety and, thus, may help to reduce food intake subsequent to consumption of the mixture.

According to the invention, there is thus provided use of a mixture comprising a triglyceride oil and an emulsifier for increasing the transit time of a foodstuff through the gastro-intestinal tract of an individual, which foodstuff is consumed concomitantly with or subsequent to administration of the mixture.

The invention also provides use of a mixture comprising a triglyceride oil and an emulsifier in the manufacture of a medicament for increasing the transit time of a foodstuff through the gastro-intestinal tract of an individual, which foodstuff is consumed concomitantly with or subsequent to administration of the mixture. The invention also concerns use of a mixture comprising a triglyceride oil and an emulsifier for improving compliance with a meal replacement regime. The invention further provides: a mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier for increasing the transit time of a foodstuff through the gastro-intestinal tract of an individual, which foodstuff is consumed concomitantly with or subsequent to administration of the mixture; a mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier for improving compliance with a meal replacement regime; a method for increasing the transit time of a foodstuff through the gastro- intestinal tract of an individual, which method comprises the step of administering to the individual an effective amount of a mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier concomitantly with or prior to consumption of the foodstuff; and - a method for improving compliance with a meal replacement regime, which method comprises the step of administering to the individual an effective amount of a mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier.

Brief description of the drawings

Figure 1 shows a schematic representation of the study design. Figure 2 shows the average level of sulfapyridin 0-11 hours after intake (n=15) of active and placebo treatment

Detailed description of the invention

Throughout the present specification and the accompanying claims, the words

"comprise" and "include" and variations such as "comprises", "comprising", "includes" and "including" are to be interpreted inclusively. That is, these words are intended to convey the possible inclusion of other elements or integers not specifically recited, where the context allows.

The articles "a" and "an" are used herein to refer to one or to more than one (i.e. to one or at least one) of the grammatical object of the article. By way of example, "an element" may mean one element or more than one element.

This invention relates to the use of a mixture in order to increase transit time through the gastro-intestinal tract of an individual of a foodstuff which is consumed concomitantly with (i.e. at about the same time) or subsequent to administration (for example consumption) of the said mixture. -A-

That is to say, the mixture may be used to increase the transit time through the gastro-intestinal tract of a foodstuff consumed together with or after the mixture. The mixture may thus be used in order to slow the transit time through the gastro-intestinal tract of a concomitantly or subsequently-consumed foodstuff. This may help to induce satiety and thus reduce subsequent energy intake,

The increase in transit time (or the slowing in transit time) through the gastrointestinal tract is an increase (or slowing) in comparison with the transit time of an equivalent food stuff in an individual consumed in the absence of the mixture

The mixture may be used in this way for a health, for example therapeutic, reason (for example in an individual who is classified as overweight), for a prophylactic reason or for a cosmetic or other non-therapeutic reason (for example in an individual who is not classified as being overweight).

The mixture comprises a triglyceride oil and an emulsifier. The triglyceride oil may have a solid fat content at ambient to body temperature The mixture may consist essentially of a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier. The mixtures/compositions that may be used in the invention are described in more detail below.

When the mixtures, or compositions, described herein were used as a food supplement for human individuals, it was observed that gastro-intestinal transit time, in particular the orocecal transit time (i.e. the time needed to cover the distance from mouth to cecum/caecum thus to the beginning of colon), of a subsequently consumed meal in the individuals receiving a composition according to the invention (test individuals) was significantly higher than in those individuals that did not receive any of the mixture (control individuals). That is to say, the gastro-intestinal transit time was slowed in the test individuals.

In more detail, the participants in the study reported in the Examples consumed a breakfast consisting of a yoghurt containing Fabuless™ (DSM Food Specialties, Delft, The Netherlands) or yoghurt without Fabuless™. These individuals then consumed a lunch consisting of a nutritional drink along with 800 mg of salazopyrin. This drug is normally used to treat inflammations in the small intestine and is degraded in the caecum by a bacterial enzyme to a metabolite (sulfapyridin) which can be detected in the blood. For the time period 0 to 4 hours after consumption of salazopyrin, no significant difference was found between the two treatments (p = 0.9156) and the level was still close to the zero-level. For the time period 5 to 11 hours after consumption of salazopyrin, however, there was a significant difference between the two treatments (p = 0.0391 ). Between 4 and 5 hours after consumption of salazopyrin, the level of sulfapyridin in the non-Fabuless™ group increased significantly more with respect to the Fabuless™ group. Between 5 and 11 hours, the increase of the level of sulfapyridin is, for both treatments, practically the same. This indicates that Fabuless™ delayed the gastrointestinal transit time of salazopyrin and can, therefore, be used in weight management, i.e. by decreasing subsequent energy intake through the induction of satiety.

The term gastro-intestinal transit time herein may refer to the time for foodstuff to pass through the entire gastro-intestinal tract or a portion thereof. The term may refer to the time taken for a foodstuff to reach a specified point in the gastro-intestinal tract, such as the lower intestine or caecum as measured from the time of ingestion. Thus, in use according to the invention, the orocecal transit time may be increased.

The term "increase/increased/increasing" gastro-intestinal transit time, and the like, implies that the gastro-intestinal transit time of a foodstuff in an individual consuming the mixture described herein is greater than the gastro-intestinal transit time in an individual subject to substantially the same dietary regime, for example wherein the mixture were to be replaced with an equivalent amount of fat (such as fat from milk). The same applies to orocecal transit time, for example.

That is to say, the gastro-intestinal transit time of a foodstuff in an individual consuming the mixture described herein (concomitantly or prior to consumption of the foodstuff) will be greater (i.e. slower) than an individual who does not consume the mixture (or consumes an equivalent amount of fat such as from milk).

Accordingly, the gastro-intestinal transit time (of a concomitantly or subsequently consumed foodstuff) will be greater in an individual consuming the mixture described herein than in an individual which does not consume the mixture.

Thus, at any given time after consumption of the (concomitantly or subsequently consumed foodstuff), there will be more of the concomitantly or subsequently consumed foodstuff and at any given point in the gastro-intestinal tract in an individual who has not consumed the mixture than in an individual who has not consumed the mixture. Also, the concomitantly or subsequently consumed foodstuff will be observed at any given point of the gastro-intestinal tract more quickly in an individual who has not consumed the mixture than in an individual who has not consumed the mixture.

In an individual who has consumed a mixture according to the invention, a concomitantly or subsequently consumed foodstuff may first arrive (i.e. be detectable), for example, about 5 minutes, such as about 10, minutes, such as about 15 minutes, such as about 20 minutes, such as about 30 minutes, such as about 40 minutes, such as about 50 minutes, for example about 60 minutes or more later after the foodstuff arrives at the same point in an individual who has not consumed the mixture. The point in the gastro-intestinal tract may be, for example, the caecum or the lower intestine.

The amount of the concomitantly or subsequently consumed foodstuff present at a point in the gastro-intestinal tract of an individual who has consumed the mixture may be at least about 10% less, for example at least about 25% less, such as at least about 50%, at least about 100% less than at the equivalent point in an individual not consuming the said mixture.

The differences specified above may be observed over a period of from about 1 hour, about 2 hours, about 3 hours or about 4 hours to about 6 hours, about 7 hours, about 8 hours, about 9 hours, about 10 hours, about 11 hours, about 12 hours or longer.

The mixture described herein may be used after a period of weight loss. Such weight loss may have been accomplished by treatment intervention or by an individual's own efforts. Typically, the term "weight loss" refers to achieving a weight loss of at least about 2% of initial or baseline body weight, such as at least about 3%, at least about 4%, at least about 5%, at least about 7%, at least about 10% or even at least about 15%. Such weight loss may be achieved over a period of from, for example, one, two or three to five, six, ten, eighteen or more weeks. Alternatively, weight loss may also be expressed as losing 2 or more body mass index (BMI) points over the period set out above.

An individual using a mixture according to the invention may be subject to a dietary regime which results in a negative energy balance. That is to say, use according to the invention may take place, wherein the individual is subject to negative energy balance. Energy balance is defined as energy intake minus energy output. An individual is described as being in negative energy balance in the event that energy intake is insufficient to meet the requirements of maintenance and production. That is to say, an individual in negative energy balance is one wherein calorie intake (from food and drinks) is less than calorie expenditure (through metabolism and energy expended during daily activities). An individual is in neutral energy balance when the energy intake is approximately equal to the energy output. For the purposes of this invention, an individual subject to a negative energy balance may be at any degree of negative energy balance. Typically, the individual will be in negative energy balance as determined on a daily basis, although an individual may be in negative energy balance for the purposes of this invention as determined over a period of time longer or shorter than one week, for example over a period of about 12 hours or over a period of about 1 week, about two weeks, about 6 weeks or longer, preferably for the entire period that the mixture described herein is consumed.

An individual subject to negative energy balance may be one in which the energy intake is about 90% or less, about 80% or less, about 70% or less, about 60% or less or about 50% or less than the energy intake required to achieve a neutral energy balance.

The calorie intake required to maintain a neutral energy balance will vary according to a wide number of variables. However, the recommend calorie intake for a woman leading typical moderately active lifestyle is in the region of from about 2000 to about 2200 kilocalories per day. The figure for a moderately active man is from about 2500 to about 2800 kilocalories per day. These figures may though need to be adjusted for age, for example old (over about 70 years old) or young (under about 10 years old) individuals generally require a lower energy intake to achieve a neutral energy balance. Also, very active individuals are likely to require a higher energy intake to achieve a neutral energy balance. A dietician will be able to advice as to the approximate energy intake required to achieve a neutral energy balance (and, therefore, the energy intake required to achieve a specific, desired degree of negative energy balance).

Accordingly, for the purposes of this invention, an individual may be generally considered in negative energy balance if they consume less than from about 2000 to about 2200 kilocalories per day (for a female) or less than from about 2500 to 2800 kilocalories per day (for a male). However, individuals consuming more than these energy amounts may, nevertheless, be in negative energy balance depending on their specific circumstances.

Such a dietary regime, where an individual is in negative energy balance, may be referred to as a Low Calorie Diet (LCD). A diet which achieves an energy intake of 800 kcal or less is defined as a Very Low Calorie Diet (VLCD). Individuals using a mixture according to the invention may be subject to a LCD or VLCD.

The Swedish Food Administration advises that three meals are taken each day along with 1 to 3 snacks in order to achieve neutral energy balance. The distribution of energy is recommended to be as follows: breakfast - from about 20% to about 25%; lunch - from about 25% to about 35%; and dinner - from about 25% to about 35%. This suggests that energy intake at lunch may be from about 500kcal to about 770kcal (women) and from about 625kcal to about 890kcal (men). Negative energy balance may thus be achieved by reducing the energy intake at one or more meals, for example lunch (with reference to the energy amounts set out above) and/or dinner and/or breakfast, whilst maintaining a normal (neutral) energy intake for the remaining meal or meals.

An individual using a mixture in accordance with the invention may be subject to a meal replacement regime. That is to say, use according to the invention may be carried out, wherein the individual is subject to a meal replacement regime, i.e. is using a meal replacement product. This may be a convenient way in which a negative energy balance may be achieved. In such regimes, meal replacements, for example in the form of a liquid or a solid bar, are consumed by the individual in place of one, two or more regular daily meals. In addition, the dieter may consume one, two or more meals of real food (which may be calorie-controlled, for example providing from about 400kcal to about ΘOOkcal per day). Some liquid diet programs offer pre-packaged meal-options for these "real" meals. Meal replacement products contain typically from about 100 to about 400 kcalories, for example from about 150 to about 250kcal. They may contain at least about 25% protein and at least about 3 vitamins and minerals. Most commercially-available products contain around 5 to 6g fibre.

Such a diet may typically provide a total energy intake of from about IOOOkcal to about 1500kcal per day, for example from about 1200kcal to about 1400kcal per day.

An individual using a mixture according to the invention may be subject to a VLCD. This is defined medically as a diet of 800kcal per day or less. VLCDs are formulated, nutritionally complete, liquid meals. VLCDs also contain the recommended daily requirements for vitamins, minerals, trace elements, fatty acids and protein. The VLCD products are usually a powder which is mixed with water, juice, or other low calorie liquid. Such diets are typically undertaken with medical supervision.

The mixture of the invention may be used to aid compliance with a meal replacement regime, a LCD or VLCD. This is because the mixture of the invention causes a subsequent meal replacement, LCD or VLCD product to pass more slowly through the gastro-intestinal tract so that a feeling of satiety is induced or reinforced such that the individual may more readily tolerate the lower level of energy delivered by the meal replacement product, the LCD or VLCD. By aiding compliance is meant that an individual consuming the mixture in the context of a meal replacement regime, an LCD or VLCD may maintain that regime over a longer period of time (than would be the case for an individual who does not consume the mixture in combination with the meal replacement regime, an LCD or VLCD). Accordingly, a mixture of the invention may be used to together with a meal replacement product or regime, an LCD or a VLCD to increase compliance with that regime, LCD or VLCD.

The mixtures that may be used in the invention are advantageously oil-in-water emulsions. In this application, the term Oil-in-water emulsions" refers to liquid oil dispersions as well as to solid fat dispersions, that is suspensions. The amount of triglyceride oils (wt%) may vary depending on the envisaged application and the nature and characteristics of the triglyceride oil as is taught herein. It can be envisaged that a composition according to the invention contains 5, 10, 15, 20, 30, 40, or even 60 or more wt% of triglyceride oils up to maximum dispersibility, i.e. when there is still a water continuous phase.

A triglyceride oil used in the invention may have a solid fat content at ambient to body temperature. With the phrase "having a solid fat content at ambient to body temperature" it is meant that there should be a solid fat content in the whole interval between ambient and body temperature. The meaning of "a solid fat content" is known to the skilled person and may be determined using standard methodology, as for instance is provided at wvw._ιminispec_:ιco_ιm/_ιap_ιf3li_ιc^tion_ιs/solj_ιd fat content.html . Expressed in another way, the term means that there should be at least a residual and detectable solid fat content at body temperature. Residual and detectable solid fat contents may be in the order of more than 0,1%, such as 0,5%, 1%, 2%, 3%, 5%, 10% or more. Solid fat content may be determined by Benchtop NMR using ISO 8292 or IUPAC 2.z150 methods. These methods yield a melting curve from which it can be easily determined whether a given triglyceride oil has a solid fat content in the range of ambient to body temperature. Additional methods for determining solid fat content include AOCS methods: AOCS Cd 16b-93 revised in 2000; Direct Method; and AOCS Cd 16-81 revised in 2000, Indirect Method.

Ambient temperature is used to indicate approximate room temperature being the temperature wherein the composition is used according to the invention. Usually this is approximately 20 ⁰C, such as 18, 19, 20, 21 or 22 ⁰C.

Body temperature differs slightly from species to species, herein this term is used to indicate the body temperature of the human individual to be treated. Usually this is approximately 37 ⁰C, such as 36, 36.5, 37, 37.5 38, 38.5 or 39 ⁰C.

The invention is particularly useful for increasing body fat mass loss in overweight or obese individuals. For practical purposes, it is generally agreed that overweight is present if the body weight exceeds the "desirable weight", whereas obesity is present if the body weight is 20% or more above the "desirable weight". Desirable weights for humans can be defined according to Metropolitan Height and Weight Tables as the midpoint of the range of the medium-frame individuals. The invention may though be useful in a non-overweight, non-obese individual who wishes to lose body fat mass for cosmetic purposes. The term "Triglyceride" as used herein refers to triacylglycerol, that is glycerol esterified to three fatty acids.

The triglyceride oils of said mixtures or oil-in-water emulsions can be any triglyceride material, or triglyceride-containing material. A triglyceride oil for use in the invention may have a solid fat content at ambient to body temperature. The triglyceride oils may be defined by the percentage of solid fat content, determined by NMR serial measurements as described in IUPAC method no. 2.150, 7th edition.

The triglyceride oils are preferably confectionery fats, such as palm oil, cocoa butter or other. Further examples of suitable triglyceride oils are illipe butter, shea butter, kokum butter, sal butter or other natural oils or fractions thereof with a similar solid fat content or melting range. Other examples of such oils are hydrogenated or partly hydrogenated soybean oil, rapeseed oil, cotton oil and sunflower oil or fractions thereof. The triglyceride oils may also be synthetic or semi-synthetic.

The term "confectionary fat" refers to special fats for confectionary applications and is known in the art. Cacao butter is the best known representative of this group, confectionary fats are also often referred to as cacao butter alternatives or cacao butter equivalents, sometimes also as cacao butter replacers or cacao butter substitutes.

The term synthetic or semi-synthetic refers to substances that are not entirely natural and/or obtained by chemical synthesis.

The invention especially refers to the use of compositions wherein the triglyceride oils comprise a fraction of palm oil. That is to say, a triglyceride oil used in the invention may be obtained from fractionated palm oil. This fraction of palm oil may be obtained from commercial palm oil, which may be fractionated to specific mixtures of suitable triglycerides, based on the combination of mainly palmitic, oleic, linoleic and stearic esters of glycerol, respectively. Preferred fatty acids for use in the invention are therefore selected from the group consisting of palmitic acid, oleic acid, linoleic acid and stearic acid. Even more preferred compositions comprise at least two fatty acids selected from the group consisting of palmitic acid, oleic acid, linoleic acid and stearic acid. Particularly good results were achieved when 20 - 80%, such as 30 - 70% of fatty acids were used selected from the group consisting of palmitic and stearic acid, and 80 - 20%, such as 70 - 30% fatty acids selected from the group consisting of oleic and linoleic acid. It should be noted that these amounts do not necessarily have to add up to 100%, i.e. they do not necessarily exclude the presence of additional fatty acids such as Laurie acid. The triglyceride oils may contain at least 90 % by weight of triglycerides, such as more than 95 % by weight. Also, the content of triglycerides in the palm oil fraction may be 99 % or more by weight. The purity can be checked by conventional chromatographic methods, such as thin-layer chromatography or high-performance liquid chromatography. It is preferred that the triglyceride oils utilised in the emulsion are pure and free from unwanted contaminants when used for pharmacological purposes

Any emulsifier may be used in the invention, however, food emulsifiers are preferred. Food emulsifiers are emulsifiers commonly used in food applications and are generally esters composed of a hydrophilic and a lipophilic part. In general, the lipophilic part comprises stearic, palmitic, oleic, or linoleic acid or a combination of said fatty acids. The hydrophilic part generally comprises hydroxyl, carboxyl, or oxyethylene groups.

Examples of families of food-grade emulsifiers are lecithins, mono-and diglycerides, propylene glycol monoesters, lactylated esters, polyglycerol esters, sorbitan esters, ethoxylated esters, succinylated esters, fruit acid esters, acetylated mono and diglycerides, phosphated mono-and diglycerides and sucrose esters. The emulsion of the triglyceride oils can also be obtained when the oils are mixed with suitable foods or food products, making use of the inherent emulsification properties of said foods or food products. Food emulsifiers according to the invention may be able to emulsify more than 20 % by weight of the triglyceride oils, preferably more than 40 % by weight, giving an emulsion which is still liquid in order to facilitate the processing of a food product in which the emulsion may be incorporated.

A preferred emulsifier of the invention is lecithin, for instance produced from egg yolk, milk, soybean oil, sunflower oil or rapeseed oil, which consists of a mixture of mainly phospholipids, such as phosphatidylcholine and phosphatidylethanolamine. Lecithin refers in this context to crude mixtures of said phospholipids which are obtained on degumming of the starting materials, and which are commercially available as food emulsifiers.

A particularly preferred emulsifier is a galactolipid-based emulsifier. Thus, an emulsifier for use in the invention may comprise one or more galactolipids. Galactolipids belong to the group of glycolipids, well known constituents of plant cell membranes. The most important classes of these contain one to four sugars linked glycosidically to diacylglycerol. The two most abundant classes contain one and two galactose units, respectively, and the commonly used nomenclature and abbreviations of these are mono- and digalactosyldiglyceride (MGDG and DGDG), sometimes referred to as galactolipids. Galactolipids, primarily DGDG and DGDG-rich materials, have been investigated and found to be a surface active material of interest in industrial applications such as food, cosmetics, and pharmaceutical products. Galactolipid emulsifiers are described in WO 95/20943 and WO 97/11141. Preferred sources for the galactolipid emulsifiers are cereals and grains, particularly oats.

A preferred aspect of the invention is the use of a composition wherein the triglyceride oils of the invention are combined with palm oil, palmkernel oil or coconut oil.

Particularly good results were obtained when a fractionated oat oil was used as a galactolipid based emulsifier. The invention therefore also relates to the use of a composition wherein the galactolipid based emulsifier was a fractionated oat oil.

Oil-in-water emulsions may be prepared by using the emulsifier either alone or in combination with other amphiphilic compounds, such as co-surfactants. The oil-in-water emulsion may also comprise optional additives known in the art for improving different aspects of the composition, such as flavouring agents, sweeteners, colorants, thickening agents, preservatives, antioxidants, etc.

Oil-in-water emulsions may be prepared by conventional methods. For example, a 30 wt% emulsion of a triglyceride oil in water is prepared by adding the emulsifier to the liquid triglyceride. The continuous phase may be pure water or an aqueous solution containing water-soluble additives such as isotonic agents, sweeteners, flavours, and preservatives. If necessary, the pH of the aqueous phase is then adjusted. The oil phase as well as the aqueous phase are preheated and then the oil phase is added to the aqueous phase under high-shear mixing. The pre-emulsion may then be subjected to high-pressure homogenisation.

The compositions described herein may be administered in enteric or oral doses in order to obtain the effect of increasing gastro-intestinal transit time of a concomitantly or subsequently consumed foodstuff. .Accordingly, the invention concerns a mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier for increasing the transit time through the gastro-intestinal tract of an individual of a concomitantly or subsequently-consumed foodstuff (concomitantly with or subsequent to use/administration of the mixture described herein). The invention also concerns a method for increasing the transit time through the gastro-intestinal tract of an individual of a concomitantly or subsequently-consumed foodstuff (concomitantly with or subsequent to use/administration of the mixture described herein), which method comprises the step of administering to the individual an effective amount of a mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier concomitantly with or prior to use/administration of the mixture described herein.

Preferably, the compositions are administered in the form of a food substance. Therefore, the mixture comprising the triglyceride oils plus the emulsifier may be added to solid or semi-solid foods, which then become naturally emulsified to an oil-in-water emulsion on exposure to the fluids of the gastrointestinal tract. The mixture may also contain oil- soluble additives such as antioxidants and flavours. The mixture may also be made into a ready-prepared emulsion which can be added to liquid or semi-liquid foods and drinks.

The invention particularly refers to a food composition wherein the mixture of triglyceride oils and emulsifier of the emulsion comprises 80-99 % by weight of triglycerides and 1-20 % by weight of emulsifier.

It should be emphasized that the emulsifying capacity of the emulsifier depends on the nature or properties of the emulsifier. The fractionated oat oil mentioned above can without further purification be used as an emulsifier in an amount of 1-20 % by weight of the total composition for preparing oil-in-water emulsions of 5-60 % by weight of triglycerides. The galactolipid emulsifier of WO 95/20943 should be used in 0.1-5.0 % by weight of the total composition for preparing oil-in-water emulsions of 5-80 % by weight of triglycerides.

The mixture can be used in formulation of dairy products, such as yogurt, ice cream, margarines, spreads, salad oils and dressings, processed meat products, confectionery, fillings, sauces, soups, fruit drinks, desserts, baby foods, but also nutritional and pharmaceutical supplements. Especially the oily mixture can be used in solid or semi-solid foods such as chocolates, other candies, baked goods and any other appropriate foods.

The invention also refers to the use of a dairy product comprising 1-30 % by weight, preferably 2-15 % by weight of the oil-in water emulsion. A preferred dairy product, such as a yogurt, may comprise 4-10 % by weight of an emulsion of a triglyceride fraction of palm oil and fractionated oat oil.

In order to obtain the desired effect of body fat mass loss or maintenance of blood pressure, an emulsion of, for example, about 40 wt% may be taken. The emulsion may be in an amount of from about 1 to about 200 ml per serving or meal, alternatively from about 5 to about 100 ml or from about 10 to about 30 ml. The oil component alone, that is the oily mixture, may be used in proportionally smaller quantities.

The mixture described herein may be taken daily for a period of for at least 1 week, at least 2 weeks, at least 4 weeks, at least 8 weeks, at least 12 weeks, at least 16 weeks or longer. The aim of the invention may be achieved when the mixture is taken for a single time period or for multiple time periods interspersed with periods of a diet in which the mixture is not taken, for example a diet of neutral energy balance.

The invention also provides use of a mixture comprising a triglyceride oil and an emulsifier in the manufacture of a medicament for increasing the transit time of a foodstuff through the gastro-intestinal tract of an individual, which foodstuff is consumed concomitantly with or subsequent to administration of the mixture.

When used in a pharmaceutical composition such a composition may in addition to the oil in-water emulsion comprise a therapeutically active component other than the components according to the invention. Therapeutically active components that may be added include vitamins, minerals and ethical drugs.

The following fats or oils may be used in the mixtures used in the invention. Fractionated palm oil (CPL-PaIm oil, LTP Lipid Technologies Provider AB, Svangsta, Sweden) obtained by fractionation of refined palm oil from AAK AB, Karlshamn, Sweden.

As emulsifiers, the following may be used: Fractionated oat oil (LTP Lipid Technologies Provider AB, Svangsta, Sweden) comprising about 20 % DGDG, and prepared from oats in-accordance with WO 97/11141 ; or Galactolipids (CPL-Galactolipids,

LTP Lipid Technologies Provider AB, Svangsta, Sweden) comprising about 60 % DGDG, and prepared from oats in accordance with WO 95/20943.

The Fractionated palm oil used may have the following fatty acid composition as determined by means of gas-liquid chromatography after alkaline methanolysis: 40-45 wt% palmitic acid, 38-42 wt% oleic acid, 8-10 wt% linoleic acid, and 4-5 wt% stearic acid, the remainder being selected from the group consisting of lauric acid, myristic acid, arachidic acid and palmitoleic acid.

The Fractionated palm oil may have a triglyceride (TG) content of 99.8-100.0 wtB, a solid fat content at 20 and 35 C (N and N35) of 31 and 6, respectively.

In yet another embodiment the invention provides a kit of parts comprising a foodstuff and a mixture comprising a triglyceride oil and an emulsifier as described above. In a preferred embodiment said foodstuff is a meal replacer. The invention is illustrated by the following Examples:

EXAMPLES Example 1

Fabuless™ emulsion

Preparation of 42 wt% emulsions with Fractionated palm oil (batch size 30Og).

Ingredients wt %

Water 57.5

Fractionated palm oil 40.0

Fractionated oat oil 2.5

The palm oil is melted at 5O⁰C and mixed with the fractionated oat oil. The oil phase and the water are preheated to 65-7O⁰C and then the oil phase is added to the water under high-shear mixing at 15,000 rpm for 4 min. The pre-emulsion is then divided into two parts; one part is homogenized at 400 bar, the other part at 800 bar, both for 6 cycles at 6O⁰C (Rannie homogenizer, Model Mini-Lab 8.30 H, APV Rannie, Denmark).

Both parts of the preparation result in emulsions with a similar cream-like consistency. The average particle size (Z average) is in both cases around 480 nm (Zetasizer 4, Malvern Instruments, UK).

An emulsion prepared as above (herein after called Fabuless™ and marketed by DSM Food Specialties, Delft, Netherlands) can be stored at 2-8⁰C until being used as an ingredient in the production of a product.

The emulsion described in this example can also be produced in larger volumes, for example as a batch of several tons. Moreover, the produced emulsion can be sterilized, for example by heat treatment.

Example 2

Study on short-term effects of Fabuless™ on gastric emptying and orocecal transit time in men

Introduction

A study was carried out to investigate whether or not Fabuless™ added to a yoghurt can affect the transit time through the small intestine. The primary objective was determine the effects of yoghurt with Fabuless™ on gastric orocecal transit time with the same yoghurt without Fabuless™ as placebo control. Study Design

The study was a single dose, randomized, double-blind, placebo-controlled, cross-over design with voluntary free-living male subjects. The double-blindness required that the study foods were very similar as well as packaged and labelled equivalently. The study design is illustrated in Figure 1 and the study events are set out in Table 1.

Study Assessments and Procedures

TELEPHONE SCREENING

The subjects were interviewed over the telephone regarding inclusion and exclusion criteria for the study, with the exception of inclusion/exclusion criteria determined by blood sample evaluation. The subjects received oral information regarding study procedures and requirements. Written information was sent to the subjects before the screening visit.

SCREENING VISIT (WEEK -2, 14±3 days;

The subject was in a fasted state (fasting for 12 hours prior to the visit) on arrival at the clinic. The following were performed: the subject received written and oral information about the study. the subject was asked to sign a written consent. the subject was asked to sign a written bio bank consent. demographic data were confirmed (age and ethnicity). - urine sample was collected. body weight, height and BMI were measured. the subject was asked about concurrent medication/supplements. inclusion/exclusion criteria were confirmed. a medical doctor conducted a clinical examination including: physical status; throat; lymph glandular; thyroidal; heart; vessels; blood pressure in sitting position, heart and pulse rate; respiratory; abdomen; and neurology blood sampling for safety analysis including; total B-hematotlgy, P-creatinine, P- alanine transaminase (P-ALAT), P-aspartate transaminase (P-ASAT), total P-bilirubin, P- alkaline phosphatase, S-thyroid stimulating hormone (S-TSH), gamma-glutamyl transferase (P-γGT) and B-HbAIc urine sampling for; glucose, blood and protein

DAY BEFORE VISIT 1 (DAY -1 )

The day before visit 1 , the subjects received standardized meals for the entire day, including breakfast, lunch, in between meal and dinner. The energy level was fixed to approximately 2900 kcal per day. All foods were distributed by study personnel to the subjects together with a form in which the subjects were required to fill in when they ate the standardized foods and if they did not eat. The subjects were also obliged to avoid heavy exercise and alcohol consumption before visit 1.

VISIT 1 (WEEK 1 , DAY -1 AND DAY 1 )

Prior to visit 1 , blood samples taken at the screening visit were reviewed and it was decided if the subject could proceed in the study (see Figure 1 ). At visit 1 , the following were performed: the subject was randomized subject was asked if he is fasting body weight was measured - the subject was asked if he had started or changed eating any medications/supplements since the first visit a breakfast was served at 08.00 hours a lunch consisting of a nutritional drink mixed was served. Eight hundred mg of salazopyrin was served with water and thereafter a second nutritional drink was served. The lunch was served at 1 1.00 hours and the total amount was consumed within 10 minutes. blood samples were taken every 15 minutes at 1 1.00 until 12.00 hours and then every 30 minute between 12.00 to 13.00 hours. Thereafter every hour until 15.00 hours, when blood samples were taken every 15 minute for 1 hour until 16.00 and then every 30 minute until 17.00 hours and then every hour until 22.00 hours (see Figure 1 ) a dinner consisting of two nutritional drinks was served at 15.00 hours; the total amount was consumed within 10 minutes. a supper was served at 19.00 hours at 22.00 hours the subject was free to go home DAY BEFORE VISIT 2 (DAY 14)

The day before visit 2, the subjects received standardized meals for the entire day, including breakfast, lunch, in between meal and dinner (as above). The subjects were obliged to avoid heavy exercise and alcohol consumption before visit 2.

VISIT 2 (WEEK 2, DAY 7±3 DAYS)

At visit 2 the same procedure was carried out as at visit 1.

FOLLOW-UP VISIT3 (WEEK 6, DAY 43±3 DAYS) a medical doctor conducted a clinical examination as described above blood sampling was carried out for safety analysis including; total B-hematology, P-creatinine, P-ALAT, P-ASAT, total P-bilirubin, P-alkaline phosphatase, S-TSH, P-γGT and B-HbAI c urine sampling for; glucose, blood and protein the subject was asked if he had experienced any AEs since the last visit. the subject was asked if he had started or changed eating any medications/supplements since the first visit

Selection of subjects

SCREENING OF SUBJECTS

The subjects will be recruited from the pool of volunteers of KPL or by advertisements in the local newspaper (i.e. Upsala Nya Tidning and Uppsalatidningen) or at common/public places. Approximately 40 subjects were telephone screened to be able to include 15 subjects (males) into the study.

SUBJECT INCLUSION CRITERIA To be eligible for inclusion, the subject had to fulfill the following criteria:

Males

Age ≥20 and ≥70 years at visit 1 Body Mass Index (BMI) ≥22 and ≥28 kg/m² Habitual lunch and dinner consumption Regular evacuation habits Signed written informed consent

SUBJECT EXCLUSION CRITERIA The presence of any of the following criteria were used to exclude a subject from participating in the study:

Abnormal total B-hematology, P-creatinine, P-ALAT, P-ASAT, total P-bilirubin, P- alkaline phosphatase, S-TSH, P-γGT and B-HbAIc - Abnormal levels in urine of: glucose, blood and protein

Contra indications against salazopyrin according to FASS

Diagnosis of allergy or asthma

Consumption of more than 3 cups of coffee per day

Diets such as slimming, medically prescribed diet, vegan or macrobiotic diet, ongoing or used less then one month prior to the test

Restrained eating

Wish to become pregnant (father) during the period of the study

Consumption of fish oil or seal oil - Change in body weight more than 5 % in the last 3 months

Diastolic blood pressure ≥ 85 mm Hg at screening visit Systolic blood pressure ≥ 140 mm at screening visit

Lack of suitability for participation in the trial, for any reason, as judged by the personnel at KPL

Treatment of Subjects

DESCRIPTION OF INVESTIGATIONAL PRODUCTS

The investigational products were a yoghurt (375 g) containing 20 g of Fabuless™ 42% (active treatment) or yoghurt with dairy fat (placebo) which were served according to the randomization treatment list. The yoghurts contained per IOOgram fresh weight:

ACTIVE PRODUCT Energy 63, 6 kcal

Carbohydrates 7,6 g

Fat 2,3 g Protein 3,2 g

Ingredients: skimmed milk, Fabuless™, sugar

PLACEBO PRODUCT

Energy 65,2 kcal

Carbohydrates 7,8 g

Fat 2,3 g

Protein 3,4 g

Ingredients of the placebo product: full fat milk, skimmed milk, sugar

The study products, active and placebo, were packaged in 125 g white plastic jars with a natural yoghurt taste.

STANDARDIZED MEALS BEFORE VISITS 1 AND 2

Study meals the day before visits 1 and 2 consisted of breakfast, lunch, in between meals and dinner.

The breakfast contained: white bread (100 g), butter (Bregott 10g), Cheese 28 % fat (28 g) Cucumber (2Og), yoghurt natural 3 % fat, (300 g), Cornflakes (45 g). Energy: 797 kcal.

The lunch contained: Pasta with ham and cheese sauce (500 g), tomato (5Og), cucumber (50 g), wheat crisp bread (13 g), butter (Bregott, 5 g). Energy: 81 1 kcal.

The in-between meal contained: Raspberry Risifrutti (175 g), banana (105 g) Energy: 390 kcal.

Dinner contained: Fish gratin with dill sauce, Findus (600 g), wheat crisp bread (13g), butter (Bregott, 5 g), apple (125 g). Energy: 880 kcal. The total energy intake during one standardized day was approximately 2900 kcal. The subject was allowed to drink < 3 cups of coffee and free water amount. The same amounts of coffee and water were consumed before both visits.

STU DY M EALS AT Vl S IT 1 AN D 2

The breakfast consisted of a yoghurt active or placebo (375 g).

The lunch consist of nutritional drinks "Naringsdryck - Novartis" 2x200 ml. Nutritional fact for the nutrition drink per 100 ml: Energy 200 kcal; Carbohydrates 25 g; Fat 8,3 g; Protein 6,3 g. The dinner consisted of the same products as were served for lunch, with the same amount of drinks.

Supper consisted of "Oxpytt - Findus" 600 g. Nutritional facts supper per 100 g: Energy 620 kJ/ 150 kcal; Carbohydrates 15 g; Fat 7 g; Protein 7 g; Dietary fibre 2,5 g.

Total energy intake during visits 1 and 2 was approximately 2750 kcal per visit.

PACKAGING AND LABELING OF INVESTIGATIONAL PRODUCTS

The investigational products identically produced, packed and labeled and marked with the randomization number. Investigational products were packed in 125 g plastic jars and 3 jars were distributed at breakfast.

Assessment of Efficacy

CLINICAL ASSESSMENTS

Body weight and height

Body weight was assessed at all visits. Body weight was measured in kilograms (kg) and the subjects were scaled with indoor cloths without shoes, wallet and keys. The scale that was be used was a CL-300 BMI, Carl Liden, Gothenburg, Sweden. The same scale was used throughout the study. Height was measured in centimeters (cm) without shoes.

Blood Pressure

Blood pressure and pulse rate were assessed at screening and follow-up visits. Blood pressure and pulse rate will be measured oscillometrically (Omron M4-I, Omron Healthcare Europe B.V., Hoofddorp, The Netherlands) in a sitting position in the right arm after a resting period of 3-5 min. Totally 2 measurements with 2-5 min in between will be performed and a average of these will be calculated.

LABORATORY ASSESSMENTS

Blood samples were taken by the study nurses from the antecubital vein using Vacutainer® tubes. All samples were handled according to the samples treatment instruction obtained from Centre for Laboratory Medicine - Clinical Chemistry, Uppsala University Hospital, in Uppsala which performed the analyses.

Clinical chemistry

The analyses included in the clinical chemistry were: P-creatinine, P-ALAT, P- ASAT, total bilirubin, alkaline phosphatase, P-γGT and S-TSH. At screening visit and follow-up visit 3, one Plasma Sample Tube (PST) was collected for P-creatinine, P-ALAT, P-ASAT, total bilirubin, alkaline phosphatase. One Serum Sample Tube (SST) was collected for the S-TSH analyses at screening and follow-up visit (visit 3).

Hematology

The analyes included in the hematology was B-blood status. At the screening visit and follow-up visit 3, one ethylen-diamine-tetraacetic-acid-tube (EDTA-tube) was collected.

Diabetes

The analyses included in the diabetes was B-HbAIc. At the screening visit and follow-up visit (visit 3) one ethylen-diamine-tetraacetic-acid-tube (EDTA-tube) was collected for the B-HbAI c-analyses.

Urine

A urine sample was analysed for: glucose, blood and protein. At the screening visit and follow up visit (visit 3), the subject gave one urine sample at the clinic.

Blood samples for detecting salazopyrin/sulfapyridin One blood sample tube was taken at each blood sampling occasion (as described above). These samples were left to stand for 20-30 minutes at room temperature. Thereafter the samples were centrifuged for 12 minutes at 3600 rpm. The centrifuge that will be used was a B Braun Biotech International. The serum from the tubes was then be transferred into cryo tubes and stored at -2O⁰C until detection analyses at the laboratory for clinical chemistry at Uddevalla sjukhus.

QUESTIONNAIRES

Study Diary

A study diary was distributed to the subjects before visit 1 and visit 2. The subjects were asked to fill in date and sign every day they consume the standardized meals including different foods. They were also asked to comment on any failure in their obligations and to give a reason for not consuming the total amount of food products.

STATISTICS

Primary objectives and endpoint

The primary objectives of the study were to determine the effects of yoghurt with Fabuless™ on orocecal transit time with the same yoghurt without Fabuless™ as placebo control.

The primary objective compared the endpoint;

Change from baseline (time zero) to 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10, 1 1 hours on postprandial salazopyrin (sulfapyridin) levels between treatments.

Results

Study Subjects

The recruitment procedure resulted in 25 potentially eligible male subjects to come for a screening visit. Out of these subjects, 15 were found eligible to the run-in period and thereafter 15 subjects were randomized into active or placebo treatment.

Subject distribution showing 15 subjects on each treatment and 15 subjects were found eligible to do statistical analyses on. The screening period was during week 31 , 2007 and the study period was then running during weeks 49-51 , 2007.

Background characteristics The mean age was 29.7 years (SD 11.9)

Sulfapyridin levels

The sulfapyridin levels observed in the test subjects are summarized in Figure 2 and Table 2. These are the average levels of sulphapyridine in plasma (μmol/L) after active and placebo treatment

For statistical analysis of the results, firstly (with the procedure PROC MIXED) it was established that the error terms are sufficiently independent. Therefore the procedure GLM could be used.

Because the levels of sulfapyridin during the first 4 hours were close to zero, the total period of 11 hours was divided into two parts: part 1 : 0 - 4 hours; and part 2 : 5 - 11 hours.

In part 1 , no significant difference was found between the two treatments (p = 0.9156) and the level was still close to the zero-level.

Overall difference Placebo - Active = 0.02

In part 2 (5 - 11 hours), however, there was a significant difference between the two treatments (p = 0.0391 ). That difference was independent of the factor "hour" (p = 1.0000). This means that over the period 5 - 1 1 hours, the difference Placebo - Active is more or less the same at each time point.

Overall difference Placebo - Active = 1.6

Conclusion Between 4 and 5 hours, the level of sulfapyridin with the treatment Placebo increases significantly more with respect to the treatment Active.

Placebo 0.6 -> 2.6

Active 0.5 -> 1.1 Between 5 and 11 hours, the increase of the level of sulfapyridin is for both treatments practically the same, leaving a difference of approx. 1.6 intact.

The difference in plasma levels between active and placebo (1.6 μmol/L) when converted to time represents 45 minutes delay.

Tables

Table 1. Schedule of events

Type of action: Telephone Screening Visit Visit Follow-up

Screening visit Visit

Visit number: 1 2 3

Week -3 1 2 6

Days 1 8 43

Incl./Excl. criteria X X X²

Height X X

Weight X X

Written consent X

Written bio bank consent X

Written information about the

Λ V study

Clinical examination X X

Randomization X

Blood samples

- Sulfapyridin X X

- Safety analysis X X

Study day events according to X X fig. 1

Concomitant medication X¹ X X X

AE/SAE reporting X X

Distribution of standardized

Λ Y³ Λ Y³ meals

Distribution of palm computers X X

Economic compensation X

Concurrent medication will be taken at screening visit 2lnclusion/exclusion criteria according to blood samples will be verified. Standardized meals will be distributed and consumed the day prior to visit 1

Table 2. Average level of sulphapyridine in plasma (umol/ϋ after active and placebo treatment (n=15)

Claims

1. Use of a mixture comprising a triglyceride oil and an emulsifier for increasing the transit time of a foodstuff through the gastro-intestinal tract of an individual, which foodstuff is consumed concomitantly with or subsequent to administration of the mixture.

2. Use of a mixture comprising a triglyceride oil and an emulsifier in the manufacture of a medicament for increasing the transit time of a foodstuff through the gastro-intestinal tract of an individual, which foodstuff is consumed concomitantly with or subsequent to administration of the mixture.

3. Use according to claim 1 or 2, wherein orocecal transit time of the concomitantly- or subsequently-consumed foodstuff is increased.

4. Use according to any one of the preceding claims, wherein the individual is subject to a negative energy balance.

5. Use to any one of the preceding claims, wherein the individual is subject to a meal replacement regime.

6. Use of a mixture comprising a triglyceride oil and an emulsifier for improving compliance with a meal replacement regime.

7. Use according to any one of the preceding claims, wherein the triglyceride oil has a solid fat content at ambient to body temperature.

8. Use according to any one of the preceding claims, wherein the triglyceride oil is a confectionary fat.

9. Use according to claim 8, wherein the confectionary fat is selected from the group consisting of palm oil, cocoa butter, illipe butter, shea butter, kokum butter, sal butter, hydrogenated or partly hydrogenated soybean oil, rapeseed oil, cotton oil, sunflower oil or fractions thereof or other natural oils or fractions thereof with a similar solid fat content or melting range.

10. Use according to any one of the preceding claims, wherein the triglycerides are obtained from fractionated palm oil.

11. Use according to claim 10, wherein the triglycerides are palmitic, oleic, linoleic or stearic esters of glycerol.

12. Use according to claims any one of claims 1 to 7, wherein the triglycerides are synthetic or semi-synthetic.

13. Use according to any one of the preceding claims, wherein the emulsifier is a food emulsifier.

14. Use according to claim 13, wherein the food emulsifier comprises an ester composed of a hydrophilic and a lipophilic part.

15. Use according to claim 14, wherein the lipophilic part is composed of stearic, palmitic, oleic, or linoleic acid or a combination of said fatty acids and/or wherein the hydrophilic part comprises hydroxyl, carboxyl, or oxyethylene groups.

16. Use according to any one of claims 13 to 15, wherein the food emulsifier comprises a lecithin, a mono-and diglyceride, a propylene glycol monoester, a lactylated ester, a polyglycerol ester, a sorbitan ester, an ethoxylated ester, a succinylated ester, a fruit acid ester, an acetylated mono and diglyceride, a phosphated mono-and diglyceride or a sucrose ester.

17. Use according to claim 16, wherein the food emulsifier comprises lecithin produced from egg yolk, milk, soybean oil, sunflower oil, or rapeseed oil.

18. Use according to any one of claims 1 to 13, wherein the emulsifier comprises one or more galactolipids.

19. Use according to claim 18, wherein the emulsifier is a galactolipid.

20. Use according to claim 18 or 19, wherein the galactolipid contains one to four sugars linked glycosidically to diacylglycerol.

21. Use according to claim 18 or 19, wherein the galactolipid is a mono or digalactosyldiglyceride.

22. A mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier for increasing the transit time of a foodstuff through the gastro-intestinal tract of an individual, which foodstuff is consumed concomitantly with or subsequent to administration of the mixture.

23. A mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier for improving compliance with a meal replacement regime.

24. A mixture according to claim 22 or 23 and as defined in any one of claims 10 to 21.

25. A method for increasing the transit time of a foodstuff through the gastrointestinal tract of an individual, which method comprises the step of administering to the individual an effective amount of a mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier concomitantly with or prior to consumption of the foodstuff.

26. A method for improving compliance with a meal replacement regime, which method comprises the step of administering to the individual an effective amount of a mixture comprising a triglyceride oil, optionally having a solid fat content at ambient to body temperature, and an emulsifier.

27. A method according to claim 25 or 26, wherein the mixture is as defined in any one of claims 10 to 21.