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(12) Patent Application Publication (10) Pub. No.: US 2011/0213026 A1 Grothe Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2011/0213026 A1 Grothe Et Al US 20110213026A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0213026 A1 Grothe et al. (43) Pub. Date: Sep. 1, 2011 (54) EXTRACTS WITH LIVER-X-RECEPTOR C07D 31 7/70 (2006.01) MODULATORS, COMPOUNDS AND THEIR C07D 49.3/04 (2006.01) USE ESPECIALLY IN WEIGHT CONTROL A6IP3/04 (2006.01) (52) U.S. Cl. .......... 514/463; 514/719:568/633; 549/432 (75) Inventors: Torsten Grothe, Bochum (DE); Ernst Roemer, Bucha (DE); (57) ABSTRACT Thomas Henkel, Wuppertal (DE) The invention relates to the use, or methods (especially with (73) Assignee: INTERMED DISCOVERY regard to animals, especially human, that are in need of Such GMBH, Dortmund (DE) treatment) comprising the use, of an extract and/or one or more natural compounds from plants or parts of plants, (21) Appl. No.: 12/673,655 respectively, from a genus selected from the group consisting of Schisandra, Illicium, Kadsura, Steganotaenia and Magno (22) PCT Filed: Jul. 29, 2008 lia, alone or as Supplement, as active ingredient in the regu lation of body weight and/or fat loss and/or for the manage (86). PCT No.: ment of obesity, either in humans or in animals, to the use of said extract and/or natural compound(s) or mixtures in the S371 (c)(1), manufacture of a pharmaceutical or nutraceutical formulation (2), (4) Date: Feb. 16, 2010 for the regulation of body weight and/or fat loss and/or for the management of obesity either in humans or in animals. The (30) Foreign Application Priority Data above extract and/or compound(s) can further be used to reduce one or more adverse metabolic parameters in a Sub Aug. 16, 2007 (EP) .................................. 07.016037.9 ject. The invention relates also to said extract and/or com pound(s) for use in the treatment or in the preparation of a Publication Classification medicament for the treatment of obesity, as well as their (51) Int. Cl. preparation. It also relates to pharmaceutical or nutraceutical A6 IK3I/36 (2006.01) formulations comprising said extract and/or natural com A6 IK3I/09 (2006.01) pound(s) which are useful in the regulation of body weight CD7C 43/23 (2006.01) and/or fat loss and/or for the management of obesity. Patent Application Publication Sep. 1, 2011 Sheet 1 of 4 US 2011/0213026 A1 ESI+ Chrom. (TIC) UVIVis Chrom. (TIC) Patent Application Publication Sep. 1, 2011 Sheet 2 of 4 US 2011/0213026 A1 4. 2 0 Weeks 3 -2 9. S 4 S - s -6 - - - - N - - -control (CC -8 - - Y - - extract (CIC(C/C) N o control (CIF) N 10 un- -- -- - - - - - - - - - - - - - - - - - - - - - - ------ - I D- - - extract (CIF)(CIF 12 Fig. 2 Patent Application Publication Sep. 1, 2011 Sheet 3 of 4 US 2011/0213026 A1 Relative Weight Loss 1,050 1,000 0, 9 5O 0, 9 OO 0,850 - - - 0,800 l I Week Patent Application Publication Sep. 1, 2011 Sheet 4 of 4 US 2011/0213026 A1 body weight g) white fat g) [---- (b) US 2011/02 13026 A1 Sep. 1, 2011 EXTRACTS WITH LIVER-X-RECEPTOR 0004 An increasing interest by consumers in the mainte MODULATORS, COMPOUNDS AND THEIR nance or reduction of their body weight can be found. This USE ESPECIALLY IN WEIGHT CONTROL leads to a demand for products useful for these purposes. Preferred are such food products which can conveniently be BACKGROUND consumed as part of the daily diet, for example meal replacer products, such as meal replacerbars and beverages. These are 0001. The invention relates to the use, or methods (espe usually designed for use as a single-serving food product to cially with regard to animals, especially human, that are in replace one or two meals a day. need of Such treatment) comprising the use, of an extract 0005. An issue is that often a saturating effect is missed and/or one or more natural compounds from plants or parts of when such products are consumed, resulting in hunger feel plants, respectively, from a genus selected from the group ings only a relatively short time after consummation or even consisting of Schisandra, Illicium, Kadsura, Steganotaenia in the lack of a saturation feeling already directly after con and Magnolia, alone or as Supplement, as active ingredient in Summation. the regulation of body weight and/or fat loss and/or for the 0006 Summing up, there remains a need for safe and management of obesity, either in humans or in animals, and/ effective compositions for promoting weight loss and/or loss or to the use of said extract and/or natural compound(s) or of body fat in subjects such as humans. The problem to be mixtures in the manufacture of a pharmaceutical or nutraceu solved by the present invention is therefore to find composi tical formulation for the regulation of body weight and/or fat tions or compounds useful in the treatment of obesity. loss and/or for the management of obesity either inhumans or 0007 Phytochemistry provides a large pool of compounds in animals. The above extract and/or compound(s) can further and compositions to be looked at whether they are able to be used against inflammation. The invention relates also to solve this problem. said extract and/or compound(s) for use in the treatment or in 0008 Plants like Schisandrachinensis are known from the the preparation of a medicament for the treatment of obesity, traditional Chinese medicine (TCM) as Wu Wei Zi. The as well as their preparation. It also relates to pharmaceutical TCMs are essential components of alternative medicines. or nutraceutical formulations comprising said extract and/or Many TCMs are known to alter the expression of hepatic natural compound(s) which are useful in the regulation of drug-metabolizing enzymes and transporters. The molecular body weight and/or fat loss and/or for the management of mechanisms by which TCMs and/or their constituents regu obesity. late enzyme and/or transporter expression, however, have 0002 Weight control is a concern of human beings. More remained largely unknown. importantly, excessive accumulation of body fat (i.e. obesity 0009 Plants used in medicine originate from all areas on (adiposity), especially with excessive fat in the ventral earth. They or compounds or extracts therefrom are, for region and Surrounding the viscera)) can be dangerous and example, used in traditional medicine. Thus, Schizandrin B is has been linked to health problems such as type II diabetes, a hepato- and cardioprotective ingredient isolated from the hypertension, heart disease, atherosclerosis (where more than fruit of Schisandrachinensis, a traditional Chinese herb clini two of the preceding disorders are present, the condition is cally used to treat viral and chemical hepatitis (see Chiu PY. often called “Metabolic Syndrome'), hyperlipidemia, coro et al., Mol. Cell. Biochem. 2004 266(1-2): 139-44). Extracts nary heart disease, stroke, breast and colon cancer, sleep from the fruits (seeds) of Schisandra chinensis L. and pure apnoea, gallbladder disease, gastroesophageal reflux disease, isolated Substances are one of the components of medicinal fatty liver, gout or thromboembolism. Obesity is one of the preparations designed for the treatment of cardiovascular dis main factors in the development of cardiovascular diseases. eases, liver diseases, as a Supplement in the treatment of As a side effect the levels of cholesterol, blood pressure, neoplasms, diabetes, and the like (see Opletal L et al., Kren blood Sugar and uric acid in obese people are usually higher kova M. Havlickova P: Phytotherapeutic aspects of diseases than those of persons of normal weight. The morbidity from of the circulatory system. 8. Chinese magnolia (Schisandra coronary heart disease among the overweight people is chinensis (Turcz.) Baill.): production of the drugs and their increased as well. Among the people aged 40-50, mortality evaluation, therapeutic and dietary preparations. Ceska Slov. will rise about 1% when body weight increases by 0.5 kg and Farm. 2001 50(5):219–24). the death rate will increase 74% when body weight exceeds (0010. The Dictionary of Natural Products quotes 151 dif 25% of the standard. The prevalence of obesity in the United ferent compounds for the class of dibenzoa,ccyclooctadiene States has more than doubled since the turn of the last century lignans (see Dictionary of Natural Products, Version 15:1, (whole population) and more than tripled within the last 30 Chapman & Hall/CRC 2007). Several biological activities years among children aged from 6 to 11. This problem more are named, such as: inhibition of P-glycoprotein and of mul and more becomes a disease risk also in Europe. In Germany, tidrug resistance-associated protein-1, inhibition of HIV-1 particularly many people have been found to suffer from protease, and inhibitory activity on NFAT transcription (see overweight recently, already 25% of the young people, chil Lee IS et al., Planta Med. 2003 69(1):63-4). Complex mix dren and adolescents there are affected by obesity and related tures like plant extracts containing Schisandra sp. from TCM disorders. Furthermore, being overweight is considered by were reported to exhibit activities like: activation of the preg the majority of the Western population as unattractive. nane X receptor and increase of warfarin clearance in rats (see 0003) Determinants of obesity include social factors, psy MuYet al., J. Pharmacol. Exp. Ther: 2006 316(3): 1369-77), chological factors, genetic factors, developmental factors and antibacterial activity against Salmonella (see Lee M H et al., decreased physical activity. Some components of a compre Int. J. Food Microbiol. 2006 111(3):270-5) or against Heli hensive weight loss programs include medical assessment, cobacter pylori (see Li Y et al., J. Ethnopharmacol. 2005 behavioural and dietary modification, nutrition education, 98(3):329-33), endothelium-dependent and -independent mental and cognitive restructuring, increased physical activ relaxation of isolated rat thoracic aorta (see Rhyu MR et al., ity, and long term follow-up.
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