GB2462484A

GB2462484A - Composition comprising Caralluma fimbriata, Shuddha guggulu, and Triphala extracts

Info

Publication number: GB2462484A
Application number: GB0814657A
Authority: GB
Inventors: Marjorie Winters
Original assignee: Individual
Current assignee: Individual
Priority date: 2008-08-11
Filing date: 2008-08-11
Publication date: 2010-02-17
Also published as: GB0814657D0

Abstract

A composition is disclosed comprising a synergistic combination of extracts of Caralluma fimbriata, Shuddha guggulu, and Triphala. The composition may be used to treat obesity or for controlling lipid metabolism, and may be formulated for oral administration. A method of controlling obesity using the aforementioned composition is also claimed, along with nutritional supplements containing the compositions, and compositions suitable for use as food additives. The compositions may also comprise beta-glucan or Bacopa monnieri.

Description

COMPOSITIONS AND METHODS FOR MAINTAINING LIPID HEALTH

FIELD

The invention relates to compositions comprising a synergistic combination of natural active ingredients that control lipid health by reducing obesity and lowering cholesterol in an animal, including humans. In particular, the invention relates to a nutritional supplement as well methods of using the supplement.

BACKGROUND

Obesity represents a growing global health problem. There are currently one billion people worldwide who are considered overweight, with 30% of these categorised as being obese. The health hazards that can be directly or indirectly caused by obesity include diabetes, hypercholesterol, hypertension and coronary heart disease. The World Health Organisation estimates that a third of all cancers of the colon, breast and kidney are due in part to obesity and an associated poor diet. By 2015, the WHO estimates that the number of overweight and obese people will rise by a further 50% to a shocking one and a half billion people. The economic cost for healthcare systems addressing the myriad complications associated with obesity result in overweight individuals costing around 37% more to treat over a lifetime when compared to individuals who are within the normal range for body mass.

In the United States, 30 percent of adults are clinically obese, some 60 million people. In Europe, Britain is at the top of the list with 23 percent, nearly double the rate in Germany, where 12 percent are classed as obese. But even in European countries where obesity is less prevalent, the percentage has continued to increase steadily over time. Overall, there are some 200 million adults in the EU and close to 45% of the population are considered to be overweight. Of even greater concern is that obesity is being increasingly observed in younger adults and children. In Europe around 74 million school age children are overweight, about 15% of that number are obese. Italy, takes the lead with 36% of the children overweight.

With individuals in developed nations increasingly relying on pre-prepared foods and leading a sedentary lifestyle, it is anticipated that the prevalence of severe, or so-called morbid obesity' is set to rise in the near future. Morbid obesity is defined as having a body mass index of greater than 40 kg/rn2, which equates to being about 45kg (100 Ibs) overweight. Morbidly obese individuals are at severe risk of significant health complications or even death. The impending obesity epidemic risks counteracting the considerable advances in modern medicine achieved in the later half of the 20th Century. It is conceivable that the trend for rising average lifespan that has been seen to date in most developed nations may even go into reverse as obesity related complications lead to an increasing rate of mortality at younger ages.

It is an unfortunate truism that individuals suffering from obesity will rarely if ever become centenarians.

High blood cholesterol (hypercholesteremia) is a metabolic derangement that can be secondary to many diseases and can contribute to many forms of disease. Elevated cholesterol does not lead to specific symptoms unless it has been longstanding.

Chronic elevated hypercholesterolemia leads to accelerated atherosclerosis, which can express itself in a number of cardiovascular diseases, such as angina, heart attacks, transient ischemic attacks and strokes. The term "bad cholesterol" is often used to refer to cholesterol contained in LDL (low-density lipoprotein) which is thought to have harmful actions, and the term "good cholesterol" is often used to refer to cholesterol contained in HDL (high-density lipoprotein) which is thought to have beneficial actions.

A high cholesterol level and obesity are not necessarily always linked. However, more often than not individuals that consume elevated levels of saturated fat in their diets, thereby placing them at risk of high cholesterol, are also observed to exhibit signs of obesity. There exists a need, therefore, for novel compositions and methods for controlling and reducing both obesity and cholesterol in patients.

The mainstay of treatment for obesity is an energy-limited diet and increased exercise. Invasive procedures such as bariatric surgery, utilising an adjustable gastric band and/or stomach stapling, are being used to combat obesity. Clearly, surgical intervention with its associated risks should be regarded as a procedure of last resort, although in view of the growing obesity problem it is becoming more prevalent. Pharmaceutical solutions to the obesity problem have been proposed in the form of pancreatic lipase inhibitors, such as Orlistat. To date the diet pill solution has faltered due to the fact that they only ever address a single aspect of what is actually a multifactorial condition.

In Western nations, it is the accepted approach to seek solutions to the need to control obesity by using a targeted pharmaceutical approach, whereas non-Western medicine takes a more holistic approach to maintaining health and wellbeing.

Accusations of a lack of scientific rigour and reproducible results have been levelled at treatments based, for example, on Ayurvedic or traditional Chinese herbal remedies. Nevertheless, as modern developed society becomes increasingly concerned with the maintenance of good health into advanced age, there has been growing interest and scientific validation of treatments based on so-called traditional knowledge (1K) medicinal systems.

While it is easy to categorise obesity as a physiological condition simply related to the levels and types of foods consumed by a given individual, it is recognised that the root cause of the condition in many overweight people is in part psychological. Self esteem or a desire for personal gratification often leads people to over consume, particularly where foodstuffs high in fat or sugar are both cheap and readily available.

It is a well known cliché that when under stress there are some that will resort to excessive comfort eating of foods such as chocolate or ice cream. It is also apparent that many people defined as overweight are in denial of their status and do not consider themselves to be at genuine risk of obesity. Yet these at-risk individuals continue to lead a lifestyle that will inevitably result in continual rise in body mass. It would be ideal to be able to assist people in this pre-obesity phase by providing a prophylactic treatment, before they progress further down the road to full blown obesity.

Clearly, there exists a need for new and improved compositions that can be used as nutritional supplements intended for controlling and reducing obesity and additionally lowering cholesterol levels. There is a further need for polypill type compositions that provide a multi-factorial response to obesity, which evidently is a multi-factorial condition. The compositions should ideally be capable of addressing physiological and, optionally, psychological aspects of obesity and be suitable for consumption as a stand-alone formulation or for incorporation into other products.

SUMMARY

The present invention resides, in part, in the synergistic combination of specific plant-derived phytotherapeutic extracts. These extracts work in combination to assist in the control of lipid levels in an individual, in particular the uptake and consumption of fat as well as cholesterol metabolism. The compositions of the invention help to counter the condition of obesity by suppressing appetite, increasing metabolic energy levels, and by reducing the risk of diseases associated with severe weight problems.

Optionally, additional extracts that address the psychological aspects of obesity are also included in the composition. These and other uses, features and advantages of the invention should be apparent to those skilled in the art from the teachings provided herein.

In a first aspect the invention provides a composition for treating obesity, comprising a pharmaceutically acceptable carrier and a synergistic combination of: an extract of Caralluma fimbriata; an extract of Shuddha guggulu; and and Triphala.

In specific embodiments of the invention, the composition comprises Caralluma fimbriata extract wherein the daily dosage level is between about 100 mg and 800mg, optionally between about 200 mg and 600mg, typically between about 300 mg and 500mg, and most suitably about 500mg.

In specific embodiments of the invention, the composition comprises Shuddha Guggulu extract wherein the daily dosage level is between about 20 mg and 250 mg, optionally between about 50 mg and 200 mg, typically between about 75 mg and 160 mg, and most suitably about 160 mg.

In specific embodiments of the invention, the composition comprises Triphala wherein the daily dosage level is between about 20 mg and 200 mg, optionally between about 50 mg and 150 mg, typically between about 75 mg and 120 mg, and most suitably about 120 mg.

Further specific embodiments of the invention provide for a composition as described above that optionally also comprises a plant derived beta-glucan. Suitably the daily dosage level of beta-glucan is between about 800 mg and 1200 mg, typically about 1000 mg.

Still further specific embodiments of the invention provide for a composition as described previously that additionally comprises an extract of Bacopa monnieri.

Suitably the daily dosage level of Bacopa monnieri is between about 40 mg and 70 mg, typically about 55 mg.

In accordance with particular embodiments of the invention the compositions are formulated to be suitable for human or veterinary use. For either specified use, the compositions may take the form of a nutritional supplement.

Another aspect of the invention provides a method of controlling obesity in an individual comprising administering to a the individual a composition as described above. In embodiments of the invention the method is directed at either individuals having a body mass index (BMI) of 30 or greater (typically clinically obese individuals) and/or individuals having a BMI of 40 or greater (typically morbidly obese people).

A further aspect of the invention provides a prophylactic method for preventing obesity in a human comprising administering to a human a composition as described above, wherein the human is defined as having a body mass index of between 25 and 30, broadly considered to be indicative of the clinically overweight.

In specific embodiments of the methods of the invention obesity is suitably measured by analysing the serum levels of circulating lipids and lipid-containing complexes in sample of blood obtained from the individual.

Other aspects of the invention provide uses of a composition of the invention in the manufacture of a medicament for controlling obesity and/or lipid metabolism in a human.

A further aspect of the invention provides a composition, suitable for use as a food additive, comprising a synergistic combination of: an extract of Caralluma fimbriata; an extract of Shuddha guggulu; and and Triphala.

Particular embodiments of the invention include a food additive composition that further comprises a plant derived beta-glucan and/or an extract of Bacopa monnieri.

A further aspect of the invention provides for a foodstuff comprising the food additive composition described above. Optionally, the foodstuff is for human consumption or suitably for animal consumption.

DETAILED DESCRIPTION

All references cited herein are incorporated by reference in their entirety. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

Prior to setting forth the invention, a number of definitions are provided that will assist in the understanding of the invention.

The term "nutritional supplement" is used herein to denote a composition that is directed for recipient human and/or animal consumption and which is intended to provide additive nutritional benefit above and beyond the existing diet of the recipient.

The nutritional benefits of the supplement may include biological activities that are essentially pharmacological, although, typically nutritional supplements do not exhibit the severity of side effects associated with pharmaceutical compositions.

The term "active component" is used herein to denote specified components or ingredients that are present within the compositions of the invention and which contribute to the desired lipid modulatory activity of said compositions. The active components of the invention may be isolated compounds, or may comprise specified extracts of botanical origin. It is desirable for the active components of the invention to be standardised, that is to say provided at a specific concentration of known activity. According to the compositions of the invention the mass of active component is given in milligrams (mg) and is equivalent to the mass of compound within the composition that possesses the desired biological activity. By way of example, a composition of the invention that comprises 250 mg of Caralluma fimbriata extract per dose, is considered as comprising 250 mg of the essential combination of compounds that contribute to and define the required biological activity of the Caralluma fimbriata extract.

The term "lipid" is used herein to refer to naturally occurring hydrophobic, aliphatic, cyclic or long-chain, saturated or unsaturated organic molecules. In a dietary context lipids are often referred to as fats and serve many functions in living organisms including energy storage, as the primary components of cell membranes, as hormones and in intracellular signalling cascades. Lipids can be broadly defined as including fatty-acids and their derivatives (including tn-, di-, and mono-glycerides and phospholipids) as well as other fat-soluble sterol-containing metabolites such as cholesterol. In accordance with the invention "lipid" is also used to refer to lipid-protein complexes which serve to assist in blood transport, such as LDL (low-density lipoprotein), VLDL (very low-density lipoprotein) and HDL (high-density lipoprotein).

The present invention resides in the provision of a formulation that may be taken as a nutritional supplement or as a pharmaceutical composition that is able to control and modulate the lipid metabolism in an individual. In particular, the formulation of the present invention is able to increase metabolic consumption of stored fat (e.g. in adipose tissue) and improve the total cholesterol profile of the blood. The formulation of the invention comprises a combination of botanically derived components that surprisingly act in synergy to achieve the above-mentioned effects of lipid metabolism control.

The primary components of the formulations of the invention are described in greater detail below.

Caralluma fimbriata Caralluma fimbriata is an edible succulent plant belonging to the cactus family. It is native to India and is sometimes considered to be a famine food. It is known to possess appetite suppressant activity and is used for its weight loss and energy boosting properties. It is believed to block the activity of several enzymes invo'ved in fatty acid synthesis, including citrate lyase and malonyl coenzyme A, causing the formation of fat to be blocked and forcing fat reserves to be burned. Caralluma fimbriata is also believed to have an effect on the appetite control mechanism of the brain.

Specific active components of Caralluma fimbriata include luteolin-4-O-neohesperidoside, kaempferol-7-O-neohesperidoside, sitosterol, tomentogenin, and pregnane glycosides, including caratubersides A and B and various boucerosides. It is the pregnane glycosides that are believed to block the activity of citrate lyase, thereby blocking the formation of fat and forcing the metabolic consumption of lipid molecules. Also, it is believed that the pregnane glycosides can inhibit the hunger sensory mechanisms of the hypothalamus in the brain, thereby causing appetite suppression.

Caralluma fimbriata, and extracts thereof, can be consumed in several forms. US Patent No. 7,060,308 describes a particular method for obtaining a standardised extract of Caralluma fimbriata. However, conventional extraction techniques are known in the art and typically include standard aqueous extraction of pulverised plant material followed by drying or lyophilization to obtain a solid residue. The liquid extract or solid residue can be further purified via chromatography or filtration and then assayed for activity via conventional means.

Purely, for the purpose of designating the country of origin, the Caralluma fimbriata used in this invention was obtained from India.

Shuddha quggulu Shuddha guggulu is a gum resin that resides in the ducts located in the soft bark of the Commiphora mukul tree, a small tree of Burseraceae family that is indigenous to India. The freshly collected gum resin is pale yellow, brown or dull green in colour, whereas aged resin is dark brown in colour.

Active components within extracts of Shuddha guggulu are known regulate fat metabolism and lower cholesterol and triglyceride levels in the body whilst maintaining or improving the HDL (high-density lipoprotein, i.e. good' cholesterol) to LDL (low-density lipoprotein, i.e. bad' cholesterol) ratio (Urizar et al. Science. (2002) 296(5573):1703-6). Shuddha guggulu has many other beneficial properties, for example it is also known to have immunostimulatory effects and also possesses cardiovascular enhancement properties as well as strong anti-bacterial properties.

The primary active component of Shuddha guggulu is believed to be the sterol guggulsterone, 4,17(20)-pregnadiene-3,16-dione (Urizar et al. supra). z-guggulsterone can activate the thyroid, and regulate metabolism through the thyroid gland. The enhanced thyroid action may assist in enhancement of the metabolic consumption of stored energy reserves in humans.

A standardised extract of Shuddha guggulu is available in proprietary form as BioLipul� (Bioprex Labs, Pune, India). Purely, for the purpose of designating the country of origin, the Shuddhu guggulu used in this invention was obtained from India.

Triphala Triphala is a traditional Indian herbal formula consisting of equal parts (1:1:1 by weight) of three unrelated fruit-bearing plant species (myrobalans), namely Amalaki (Emblica officinalis -Indian gooseberry), Bibhitaki (Terminalia bellirica -a decidious tree), and Haritaki (Terminalia chebula -a flowering evergreen tree). In preparing Triphala, these fruits are typically dried, ground into powder form, and then blended together. It is conventionally used as a digestive system regulator by acting as a gentle laxative and is highly regarded in Ayurvedic medicine. The compound is extremely effective in gastrointestinal disorders. The active compounds comprised within Triphala have high affinity for the cholecystokinin (CCK) receptors in vivo. CCK is the major intestinal hormone that coordinates food digestion and satiety signals in response to food intake. Recent studies have suggested that the Triphala formulation may be useful in regulating cholesterol and circulating blood lipid levels, particularly in animal models of hypercholesteremia (Saravanan et al., Yakugaku Zasshi (2007) 1 27(2):385-388).

Triphala is also considered to be adaptogenic with strong immunomodulatory properties which has the ability to strengthen all body tissues including immune organs. Triphala's immunomodulatory properties can support the innate immune system in individuals who have recently embraked on a weight-loss programme.

Purely, for the purpose of designating the country of origin, the Triphala used in this invention was obtained from India.

Additional components that can be included in the composition of the invention, in order to provide greater functionality, are set out below.

Plant-derived beta-glucan Beta-glucan is a soluble polysaccharide component of dietary fibre. Beta-glucan obtained from the whole grain of oats and barley shows particular utility in the compositions of the present invention. The importance of whole grain in the diet has in recent times become a cardinal rule of Western-based nutritional regimes.

Oat and barley derived beta-glucan is comprised of mixed-linkage polysaccharides in which the bonds between the component D-glucopyranosyl units are either beta-i, 3 linkages or beta-i, 4 linkages. As a result, beta-glucan from barley and oats is typically referred to as a mixed-linkage (1-3), (1-4)-beta-D-glucan. The American Dietetic Association (ADA), amongst others, has indicated that soluble fibre from whole grain sources, including beta-glucan from oats and barley, may assist in reducing serum cholesterol levels and triglycerides as part of a balanced diet.

Suitably, beta-glucan can be obtained in proprietary form under the brand names BarleyTrim� and CTRlMTM or Calorie ControlTrim� (Futureceuticals, Inc.. Momence, IL, USA).

Beta-glucans, particularly from barley, are also known to possess potent immunomodulatory activity (for reviews see Descroix et al. (2006) Mini Rev. Med. Chem. Dec;6(12):1341-9; and Kim et al. (2006) J. Korean. Med Sci. 21:781-789)).

Since these glucans are not biosynthesized by mammals, it has been postulated that they are likely to activate the immune system of a mammalian recipient. The inflammatory response is often dysfunctional or poorly regulated in the morbidly obese. Additionally, the process of slimming can place strain on the immune system -particularly in individuals who have shifted from a sedentary to a more active lifestyle. Hence, the inclusion of beta-glucan in the compositions of the present invention provides a dual function of controlling serum cholesterol and also modulating the immune response.

Purely, for the purpose of designating the country of origin, the beta-glucan used in this invention was obtained from European sources.

Bacopa monnieri Also known as Water Hyssop, The leaves of Bacopa monnieri have been utilised in Ayurvedic medicine for its anti-anxiety and purported memory enhancing effects. In traditional Indian medicine Bacopa monnieri is referred to as 1Brahmi'. Dammarane-type triterpenoid saponins classified as pseudojujubogenin and jujubogenin glycosides are reported as the active components in Bacopa.

Bacopa's mechanism of action is involved with the production of nitric oxide, a key chemical messenger. Bacopa lowers glutamate concentrations, and increase the concentration of the neurotransmitter GABA in various regions of the brain. In trials, anxiety levels are shown to fall by about 20% while mental fatigue and depression also decreases. Levels of serotonin, an inhibitory neuromediator, are also increased.

The substance can influence psycho-neurological functions associated with intellectual behaviour in humans. Mental acuity is heightened and the psychological relaxation process is activated. Anti-anxiety and tranquilizing effects are attributed to protein activity and synthesis, particularly in cells of the brain, which in turn may promote short-term and long-term memory improvements and increased mental alertness.

In accordance with the present invention, the inclusion of Bacopa in the compositions enables psychological enhancement by the reducing the stress and nervous anxiety that is often associated with being overweight. Indeed, a significant part of successful weight control involves the promotion of self confidence. Bacopa supports the physiological processes involved in relaxation and also serves to control anxiety, neurosis and depressive disorders, A standardised extract of Bacopa can be obtained in proprietary form as BioMem� (Bioprex Labs, Pune, India). Purely, for the purpose of designating the country of origin, the Bacopa monnieri extract used in this invention was obtained from India.

As mentioned previously, the present invention comprises a core synergistic combination of active extracts from Caralluma fimbriata, Shuddha guggulu and Triphala and also, optionally, a plant-derived beta-glucan and/or active extract of Bacopa monnieri. In specific embodiments of the invention the compositions can be utilised as a daily nutritional supplements that enable recipients to maintain and support a healthy lifestyle.

Obesity is a multifactorial condition that presents in many ways and is associated with a myriad of linked medical conditions. The compositions of the present invention are targeted at several of the most significant contributing factors in the condition of obesity, including: * Control of thyroid function * Blocking the laying down of fat (adipose tissue) * Reduction of circulating LDL, VLDL and triglyceride levels * Increase in circulating HDL levels * Suppression of appetite * Modulation of the immune response * Increasing the rate of metabolic energy expenditure * Reduction in anxiety and improvement of psychological status Hence, unlike previous pharmacological agents or nutraceutical supplements which are directed at a single physiological aspect associated with obesity, the present invention provides a mechanism for addressing a plurality of the primary causative factors in obesity. It is believed that a single formulation with such wide-ranging effects has not been prepared or even considered previously.

In use, the compositions of the invention can be administered to a human recipient as a daily controlled dose formulation. In one embodiment of the invention, the composition is administered in the form of an orally disintegrating tablet, which dissolves quickly and has a high dose capacity. Preferably, the pharmaceutical preparation is taken twice daily, approximately one hour before mealtime. The compositions of the invention are formulated to conform with regulatory standards and typically are administered orally or via other standard routes. The pharmaceutical preparations may be in the form of tablets, pills, edible films, liquids, powders, suspensions or other suitable formulations known in the art.

Alternatively the formulation of the invention can be comprised in a liquid, emulsion or powdered solid form that can be utilised as an ingredient in other food products.

For example, a staple of many current diet regimes' is the protein shake that acts a meal replacement. The formulation of the invention can be conveniently incorporated into such a product so as to provide a convenient nutraceutical enhancement to the product. Other foodstuffs that can comprise the formulation of the invention suitably include cereals, soups, ready meals, mousses, yoghurts, beverages, smoothies, flours, snack foods, biscuits (cookies), cakes, breads and baked goods, confectionery, jams, spreads, ice creams, chewing gum, sauces, and salad dressings. In this way the desirable activity exhibited by the compositions of the invention can be provided at the same time as food intake.

The compositions of the invention are not limited to use in humans, veterinary compositions are also considered as a suitable means for facilitating lipid health in animals. Control of body mass, particularly in the form of fat, is of great importance in sporting animals such as Thoroughbred racing horses and polo ponies. Just as obesity is increasing in prevalence in humans it is also becoming more common in domestic pets such as dogs and cats. Compositions of the invention intended for veterinary use can be administered to animals as nutraceutical formulations or alternatively the formulation can be incorporated into animal feedstuffs.

The invention is further illustrated by the following non-limiting examples.

EXAMPLES

Example 1

Orally Disintegrating Tablet (OD T): This composition provides a twice-a-day nutritional supplement, which allows for a rapid release and high dose capacity. The delivery system relies on an ODT which provides the advantages of: * fast dissolve technology * high dose capacity, robust tabletting * excellent taste profile and mouth feel A single dose ODT composition contains: Caralluma fimbriata extract (65% w/w) -250mg Shuddha guggulu extract (20% w/w) -77 mg Triphala solid powder (15% w/w) -58 mg Wiw is given as percent weight of ingredient as a proportion of the total weight of the active components in the composition.

The ODT comprises a conventional fast dissolving base including pectin, mannitol, aspartame, and anhydrous citric acid. The recipient is directed to take one ODT one hour before meals twice per day.

Example 2

Hard-gel time release capsules: This composition provides a twice-a-day nutritional supplement. The delivery system allows a customised release profile for the various active components of the composition. The delivery system relies on hard gelatine or pectin capsules that comprise layered active components on a neutral core substrate thereby formulating a plurality of beadlets each with a differing release profile. This system enables targeting phasic delivery, complex and sensitive delivery profiles possible over time.

A single dose of two capsules is given one hour before a meal twice a day. Each capsule comprises Caralluma fimbriata extract (65% w/w) -125 mg Shuddha guggulu extract (20% w/w) -38.5 mg Triphala solid powder (15% w/w) -29 mg Wiw is given as percent weight of ingredient as a proportion of the total weight of the active components in the composition.

The active components are layered on a neutral core of microcrystalline cellulose and silicon dioxide. The active components are encapsulated within a conventional hard gel casing comprising hydroxymethylcellulose, gellan gum, water and potassium acetate.

Example 3

Hard-gel time release capsule The formulation is as for Example 2 but additionally comprises extract of Bacopa, so as to provide an anti-anxiety component to the composition.

A single dose of two capsules is given one hour before a meal twice a day. Each capsule comprises Caralluma fimbriata extract -125 mg Shuddha guggulu extract -38.5 mg Triphala solid powder -29 mg Bacopa monnieri extract -55 mg

Example 4

Food additive ingredient The composition of the invention can be incorporated into foods to provide added lipid-health control functionality to the food. A suitable composition that can be added as a single formulation ingredient either in solid powdered or liquid suspension form comprises active components that when incorporated into the food product generate a final dosage per serving of: Caralluma fimbriata extract -500 mg Shuddha guggulu extract-150mg Triphala solid powder -115 mg Beta-glucan -1000 mg

Example 5

The efficacy of the compositions of the invention described in any one of Examples 1-3 above can be assessed in a controlled trial (typically a standard double-blind trial). Human clinically overweight or obese volunteers are divided into two groups: a test group and a control group. Both groups are kept on controlled diets of food and beverage of known energy value (e.g. known kilojoule/kilocalorie intake) and maintained on predetermined exercise regime over a defined time period (typically around four weeks).

Over the predefined time period the test group receive a known dosage of the composition of the invention, whereas the control group receive a placebo. Several parameters are measured to determine the status of lipid health in the individuals over the time period. For example, skin fold measurements are used to determine the percentage of sub-cutaneous body fat; body mass is monitored and statistically converted to a BMI value; and total lipid profiles of blood samples are monitored to determine changes in triglyceride, HOL, VLDL and LDL levels. Associated tests can also be used during the trial, such as regular blood sugar monitoring and psychological profiling.

At the close of the trial the results of the parameter tests can be compiled to determine the level of efficacy of the compositions of the invention in achieving beneficial modulation of lipid health when compared to a placebo.

Although particular embodiments of the invention have been disclosed herein in detail, this has been done by way of example and for the purposes of illustration only.

The aforementioned embodiments are not intended to be limiting with respect to the scope of the appended claims, which follow. It is contemplated by the inventors that various substitutions, alterations, and modifications may be made to the invention without departing from the spirit and scope of the invention as defined by the claims.

Claims

CLAIMS: 1. A composition for treating obesity, comprising a pharmaceutically acceptable carrier together with a synergistic combination of: an extract of Caralluma fimbriata; an extract of Shuddha guggulu; and and Triphala.
2. The composition of claim 1, wherein the daily dosage level is: (a) between about 100 mg and 800mg Caralluma Fimbriata extract; (b) between about 20 mg and 250 mg Shuddha Guggulu extract; and (C) between about 20 mg and 200mg Triphala.
3. The composition of claim 1, wherein the daily dosage level is: (a) between about 200 mg and 600mg of Caralluma fimbriata extract; (b) between about 50 mg and 200 mg of Shuddha guggulu extract; and (C) between about 50 mg and 150mg of Triphala.
4. The composition of claim 1, wherin the daily dosage level is: (a) between about 300 mg and 500mg of Caralluma fimbriata extract; (b) between about 75 mg and 160 mg of Shuddha guggulu extract; and (c) between about 75mg and 120mg of Triphala.
5. The composition of claim 1, wherein the daily dosage level is: (a) about 500mg of Caralluma fimbriata extract; (b) about 160 mg of Shuddha guggulu extract; and (c) about 120mg of Triphala.
6. The composition of claim 1 further comprising a plant derived beta-glucan.
7. The composition of claim 6, wherein the daily dosage level of beta-glucan is between about 800 mg and 1200 mg.
8. The composition of claim 6, wherein the daily dosage level of beta-glucan is about 1000 mg.
9. The composition of claim 1, further comprising an extract of Bacopa monnieri
10. The composition of claim 9, wherein the daily dosage level of Bacopa monnieri is between about 40 mg and 70 mg.
11. The composition of claim 9, wherein the daily dosage level of Bacopa monnieri is about 55 mg.
12. The composition of any previous claim, wherein the Caralluma fimbriata extract is in the form of an aqueous extract, dry stem crude extract, or lyophilised extract.
13. The composition of any previous claim, wherein the composition is formulated so as to be suitable for oral administration.
14. The composition of any previous claim, wherein the composition is suitable for human use.
15. The composition of any of claims ito 13, wherein the composition is suitable for veterinary use.
16. A nutritional supplement comprising a composition as described in any previous claim.
17. A method of controlling obesity in an individual comprising administering to a the individual a composition as described in any of claims 1 to 14.
18. The method of claim 17, wherein the individual has a Body mass index (BMI) of 30 or greater.
19. The method of claim 17, wherein the individual has a Body mass index (BMI) of 40 or greater.
20. A prophylactic method for preventing obesity in a human comprising administering to a human a composition as described in any of claims 1 to 14, wherein the human is defined as having a body mass index of between 25 and 30.
21. A method according to claim 11, wherein obesity is measured by analysing the serum levels of circulating lipids and lipid-containing complexes in sampie of blood obtained from the individual.
22. Use of a composition according to any of claims 1 to 13 in the manufacture of a medicament for controlling obesity in a human.
23. Use of a composition according to any of claims 1 to 13 in the manufacture of a medicament for controlling lipid metabolism in a human.
24. A composition, suitable for use as a food additive, comprising a synergistic combination of: an extract of Caralluma fimbriata; an extract of Shuddha guggulu; and and Triphala.
25. The composition of claim 24 further comprising a plant derived beta-glucan.
26. The composition of claim 24, further comprising an extract of Bacopa monrileri.
27. A foodstuff comprising a composition as claimed in any of claims 24 to 26.
28. The foodstuff of claim 27, wherein the foodstuff is selected from one of: a protein shake; a cereal; a soup; a ready meal; a mousse; a yoghurt; a beverage; a smoothie; a flour; a snack food; a biscuit; a chewing gum; a cake; a bread; confectionery; a jam; a spread; ice cream; a sauce; and a salad dressing.
29. The foodstuff of claim 27, wherein the foodstuff is an animal feed.