Food compositions for reducing insulin resistance

Details Food compositions for reducing insulin resistance Food compositions for reducing insulin resistance

2002-05-22

2004-05-18

Weddington, Kevin E. (Department: 1614)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Hydrocarbon doai

C514S863000, C514S866000

Reexamination Certificate

active

06737442

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to the field of natural plant derived ingredients which have beneficial properties to health. More particularly the invention relates to ingredients derived from the Indian plant
Commiphora mukul
and their novel use in addressing the human condition of insulin resistance and health problems associated therewith.
BACKGROUND OF THE INVENTION
Insulin is a hormone well known to play a key role in maintaining blood glucose levels within healthy parameters. Where the action of insulin is impaired, as is the case in the human condition insulin resistance, a range of health problems can occur. In the short term the health problems associated with insulin resistance comprise chronic fatigue, cognitive impairment and mood swings, whilst long term they include more chronic diseases such as cardiovascular disease, type-II diabetes and polycystic ovary syndrome. Insulin resistance is therefore a complex metabolic condition and the frequency of incidence within the human population makes it highly desirable to develop a means by which it can be controlled or prevented.
PPARgamma is a known member of the peroxisome proliferator activated receptor (PPAR) subset of the nuclear hormone receptor superfamily. It is a ligand activated transcription factor and binds DNA in a heterodimeric complex with a second nuclear hormone receptor RXR. PPARgamma has been characterised as an important regulator of lipid metabolism. PPARgamma is suggested as playing a role in insulin sensitivity and other biological activities including effects on inflammation, cancer, cognition and cellular differentiation.
Commiphora mukul
has long been used as a herbal treatment for hyperlipidaemia in the form of a gum resin called “guggulipid” or “guggal lipid”, however little is known in the art about the effect of this plant at a molecular level. EP 0997149 discloses that the pharmacological activity of guggulipid is attributable to known ketonic steroids the E- and Z-guggulsterones, however contrary to expectation, the pharmacological activity of guggulipid with respect to PPARgamma receptor activity has been found by the applicants not to be attributable to these guggulsterones.
Guggulipid has been disclosed as an agent for the treatment of autoimmune diseases by virtue of its anti-inflammatory effect. In this context the autoimmune form of diabetes i.e. type-1 has been noted. Guggulipid has also been included in compositions for dietary supplementation (EP997149).
Insulin resistance is a causative agent of type-2 diabetes and is distinct from the autoimmune type-1 form. At the time of filing the influence of guggulipid on human insulin resistance and in particular the influence of guggulipid on PPARgamma receptors was not known.
The objective technical problem to be solved by the present invention is to provide food compositions comprising naturally derived ingredients which are capable of inducing human health benefits by the treatment and/or prevention of insulin resistance. In particular the invention addresses the problem of providing natural ingredients which are capable of treating or preventing insulin resistance by activating PPARgamma receptors.
The applicants have found that compounds present in the natural plant extract guggulipid offer a novel solution to the defined problem, thereby providing naturally derived ingredients capable of treating and/or preventing insulin resistance via PPARgamma receptor activation.
The prior art is silent as to any suggestion that a guggulipid extract may have PPARgamma activating properties and the applicants are aware of no connection having been established in the art between guggulipid or its components and insulin sensitivity.
BRIEF DESCRIPTION OF THE INVENTION
The problem of providing food compositions which treat and/or prevent insulin resistance in humans has now been solved by providing in a first object of the invention, a food composition for the treatment and/or prevention of insulin resistance in humans comprising an effective amount of a compound according to the formula;
wherein,
R
1
is selected from the group consisting of COOH, CH
2
OH including salts and/or esters thereof and CH
3
; and
R
2
is selected from the group consisting of OH, O and esters thereof;
wherein said compound is contained within continuous or discontinuous fat phase.
It is a second object of the invention to provide a food composition for the treatment and/or prevention of insulin resistance in humans comprising an effective amount of a compound according to the formula described above wherein said compound is contained within a continuous or discontinuous aqueous phase.
A preferred embodiment comprises a food composition as described above wherein said compound is present in an amount of at least 0.01% by weight.
It is a third object of the invention to provide a food composition for the treatment and/or prevention of insulin resistance in humans wherein said composition comprises a compound as described above in an amount of at least 3% by weight.
In a fourth object the present invention provides food composition according as described above for use in the treatment and/or prevention of diseases selected from the group comprising polycystic ovary syndrome, type-2 diabetes, gestational diabetes, syndrome X, hypertension, psoriasis and stroke.
A fifth object of the invention provides a food composition according to any one of claims 1 to 4 for use in the treatment and/or prevention of one or more symptoms of insulin resistance selected from the group comprising reduced energy levels, reduced cognitive performance, tiredness and mood swings.
In a preferred embodiment the food composition of the invention is preferably, selected from the group comprising edible spreads, mayonnaise, dressing, ice cream, dairy and non-dairy creams, confections, bakery products, soups, beverages, jam, cakes, chocolate, dietary supplements, sauces and speciality foods for type-2 diabetics.
Conventional fractions of the commercially available guggulipid extract which have been processed for food compositions have an undesirable bitterness and accordingly are unpleasant to taste. In contrast neither compounds identified by the invention nor fractions of the guggulipid extract which have been enriched for these compounds have the bitterness associated with conventional fractions of the guggulipid extract.
Particular advantage is therefore offered by incorporating either the compounds according to formula I or a fraction of guggulipid extract enriched for such compounds into a food composition. In this way the favourable health benefits are maintained with no flavour detriment.
A sixth object of the invention therefore provides for the use of a fraction of a guggulipid extract in the manufacture of a food composition for the treatment and/or prevention of insulin resistance wherein said fraction comprises at least 15 wt % of a compound according to claim 1 and less than 1.0 wt % of Z and E guggulsterones;
It has also been found that crude guggulipid extract may induce dehydration, however, these effects can be avoided by applying the novel guggulipid fractions of the guggulipid extract provided herein which are enriched for one or more compounds according to formula I in place of the crude guggulipid extract.
It is therefore a seventh object of the invention to provide a blend of a guggulipid fraction and another component wherein said blend comprises;
(i) a guggulipid fraction comprising more than 15 wt %, compound according to formula I, and;
(ii) tri and/or diglycerides including fatty acids and their esters, in such amounts that the blend contains at least 2 wt % of the guggulipid fraction.
Preferably the guggulipid fraction used in the manufacture of a food composition and in the blend will comprise more than 20 wt %, more preferably more that 40 wt %, most preferably more than 60 wt % of a compound according to the formula I.
In a most preferred embodiment the invention comprises a blend as described above wherein the compound according to formula I is 13-(deca

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