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WO 2007/053846 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date (10) International Publication Number 10 May 2007 (10.05.2007) PCT WO 2007/053846 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 36/15 (2006.01) A61K 31/202 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 36/27 (2006.01) A61K 31/704 (2006.01) AT,AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, A61P 3/04 (2006.01) CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, (21) International Application Number: JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, PCT/US2006/060434 LT, LU, LV,LY,MA, MD, MG, MK, MN, MW, MX, MY, (22) International Filing Date: MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, 1 November 2006 (01.1 1.2006) RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, 60/732,440 1 November 2005 (01.1 1.2005) US ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), 11/554,982 31 October 2006 (3 1.10.2006) US European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT, LU, LV,MC, NL, PL, PT, (71) Applicant (for all designated States except US): SOFT RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GEL TECHNOLOGIES, INC. [US/US]; 6982 BAN- GN, GQ, GW, ML, MR, NE, SN, TD, TG). DINI BOULEVARD, Los Angeles, CA 90040 (US). (72) Inventor; and Published: — with international search report (75) Inventor/Applicant (for US only): UDELL, Ronald, G. [US/US]; 527 HILLGREEN DRIVE, Beverly Hills, CA — before the expiration of the time limit for amending the 90212 (US). claims and to be republished in the event of receipt of amendments (74) Agents: ROTHENBERGER, Scott, D. et al.; DORSEY & WHITNEY LLP, INTELLECTUAL PROPERTY DE For two-letter codes and other abbreviations, refer to the "G uid PARTMENT, SUITE 1500, 50 SOUTH SIXTH STREET, ance Notes on Codes and Abbreviations" appearing at the beg in Minneapolis, MN 55402-1498 (US). ning of each regular issue of the PCT Gazette. (54) Title: COMPOSITIONS OF HOODIA GORDONII AND PINOLENIC ACID DERIVATIVES (57) Abstract: The present invention is directed to compositions containing a pine nut oil and an extract from the genus Hoodia or Trichocaulon and methods of treatment for weight loss. COMPOSITIONS OF HOODIA GORDONII AND PINOLENIC ACID DERIVATIVES CROSS-REFERENCE TO RELATED APPLICATION(S) [001] This application claims benefit under 35 U.S.C. § 119(e) to U.S. Serial No. 60/732,440, filed November 1, 2005 (Attorney docket number 187139/US, entitled "Compositions of Hoodia Gordonii and Pinolenic Acid Derivatives" and U.S. Serial No.11/401,110, filed October 31, 2006 (Attorney docket number 187139/US/2), entitled "Compositions of Hoodia Gordonii and Pinolenic Acid Derivatives", the contents of both are incorporated herein by reference in their entirety. FIELD OF THE INVENTION [002] The present invention relates to formulations, including soft gelatin capsules, that contain a combination of an extract from the genus Trichocaulon, including Trichocaulon officinale or Trichocaulon piliferum, or from the genus Hoodia, including Hoodia currorii, Hoodia gordonii or Hoodia lugardii and an extract from the genus Pinus containing pinolenic acid and/or derivatives thereof. BACKGROUND OFTHE INVENTION [003] Over the past several decades the world's population, in general, has been becoming overweight. In many instances, excessive weight gain increases the risk of diabetes, hypertension, cardiac diseases or kidney disease among other diseases or conditions related to obesity. It is not just an affliction of the elderly; in fact, many recent studies show that increasing numbers of juveniles and teenagers are developing weight related afflictions. [004] Today's sedentary lifestyle unfortunately helps to promote excessive weight gain in individuals. One of the problems with the Western diet during the last fifty years has been excessive consumption of linoleic acid, due to the introduction of margarine, seed oils such as com oil and safflower oil, and the modern artificial feeding methods of cattle that have raised the linoleic acid content of meat. At the same time, the consumption of beneficial fatty acids such polyunsaturated fatty acids (PUFAs) including omega-3 fatty acids from food sources such as fish and seeds have decreased. [005] There are many treatments and diet programs available to help promote a healthy lifestyle and weight loss. Most diet programs consist of reducing caloric intake, reducing the amount of carbohydrates consumed, and appropriate exercise. Surgical treatments are available and include stomach stapling, gastric by-pass and liposuction [006] Unfortunately, an individual will often lose weight on a diet program but then later succumb to old eating habits. Exercise often becomes a luxury due to life style constraints and the individual lapses into a cycle of dieting, weight loss, cessation of the diet and weight gain, only to repeat this process over and over. [007] Surgical procedures can be quite expensive and inconvenient. Many procedures are not paid for by insurance companies and the individual is forced with a decision to either pay for the procedure himself or herself or forgo the surgery. Additionally, surgery can result in the person not being ambulatory for a week or more and can be quite painful. [008] Weight gain is a complex problem. The health conscious public is concerned about excessive weight gain, but does not generally want to maintain strict diets to lose or maintain a healthy weight. Weight gain is often a combination of reduced metabolism of glucose, the individual's inability to block carbohydrate absorption from the diet and/or the inability to reduce body fat. A solution to one or more of these problems is sought by many people, young and old alike [009J There is a need in the art for a nutritional supplement that counteracts one or more of the afore-mentioned weight related afflictions. BRIEF SUMMARY OF THE INVENTION [01 0] The present invention pertains to compositions for appetite suppression, for the reduction of body fat, for reduction of caloric intake, to increase the feeling of satiation, to increase the release of cholecystokinin (CCK), to increase glucose metabolism, for inhibiting absorption of carbohydrates, and/or for weight loss. The invention also pertains to methods to accomplish one or more of these goals. The invention further pertains to packaged nutraceutical formulations to treat such conditions. [Oi 1] In one aspect, the present invention surprisingly provides that a combination extracts from the genus Pinus, i.e., Pinus koraiensis, which contain pinolenic acid (and derivatives thereof, such as esters including but not limited to mono-, di-, or triglycerides thereof) and an extract from the genus Trichocaulon, including Trichocaulon officinale or Trichocaulon piliferum, or from the genus Hoodia, including Hoodia currorii, Hoodia gordonii or Hoodia lugardii and/or derivatives thereof can improve one or more of the afore-mentioned health issues. [012] In certain embodiments, the compositions of the invention can further include a banaba leaf extract or derivatives thereof, conjugated lirioleic acid (CLA) or derivatives thereof, and/or a starch blocker. More specifically, the compositions can further include corosolic acid. [013] The compositions of the invention can be ingested in the form of a tablet, pill, lozenge, soft gel capsule, in a health food snack, in a drink, etc. The recommended daily amount can be taken in one or more portions. [014] The combination of extracts from the genus Pinus and Hoodia or Trichocaulon provide a synergistic combination (effect) relative to either of the extracts given alone. [01 5] Banaba (Lagerstroerαia Speciosa L.), also known as Queen's flower, pride of India, or queen's crape myrtle, belongs to the botanical family lythraceae and contains corosolic acid and other beneficial phytochemicals. Corosolic acid (2-α-hydroxyursolic acid, CAS# 52213-27-1) is a triterpenoid with a molecular weight of 743.63 daltons and is a lipophilic, polar compound that is extracted from the leaves of Lagerstroemia Speciosa L. A suitable commercial source of corosolic acid is available from Soft Gel Technologies, Inc. of Los Angeles, CA, USA, and is known by the trademark GLUCOTRIM™ (available as a 1% or 3% corosolic acid extract). [016] Conjugated linoleic acid derivatives (CLA' s) include any conjugated linoleic acid or octadecadienoic fatty acid, including all positional and geometric isomers of linoleic acid with two conjugated carbon-carbon double bonds at any position in the molecule. Additionally, the term includes salts and esters thereof, including triglycerides. [017] Starch blockers are known in the art and the term is intended to include, but is not limited to, alpha amylase inhibitors, alpha-glucoside inhibitors and glucosidase inhibitors. In particular, the present invention includes starch blockers based on derivatives from white kidney beans (Phaseolis vulgaris). Phaseolamin is a partially-purified protein extract of white kidney beans that binds to alpha-amylase enzymes, which are responsible for the digestive breakdown of starch. It has been proposed that phaseolamin inhibits the alpha- amylase breakdown of starch by non-competitively binding the enzyme to prevent the hydrolysis of the alpha- 1,4-glycosidic linkages in the starch molecule.
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