‘US 20071 cu») United States 2) Patent Application Publication co) Pub. No.: US 2007/0196520 A1 6 03) 3) a @ (6) Lin et al. METHODS AND MATERIALS FOR REDUCING OR ELIMINATING RISK FACTORS ASSOCIATED WITH SYNDROME, x Inventors: Sie Lin, Sarasota, EL (US); Tim Romero, Sarasota, FL (US) Comesponilence Address: GIFFORD, KRASS, SPRINKLEANDERSON & CITKOWSKI, P.C PO BOX 7021 ‘TROY, MI 48007-7021 (US) Assignee: FHG Corporation d/b/a Nutraceutleals Appl. Nox 11/673,063, Filed: Feb. 9, 2007 Related U.S. Applicaton Data Contnuaton-in-par of application No, 10905, 142, filed on Dec. 17, 2004, saw abandoned, 9652081 (43) Pub. Date: Aug. 23, 2007 (60) Provisional application No, 60521,157, filed on Mar 1.2008 Publication Cla ™ GI) Ime. AGIK 3654 (2006.01) (52) US. 24739 6 ABSTRACT A composition containing cinnamon extract reduces andlor liminates one or more risk factors associated with Syn- ‘drome X. The composition also includes optionally one of ‘more components selected from the group consisting of ‘vitmins, cholesterol lowering agents, lipid lowering agels, And glucose lowering agent. Also described is a method of reducing andlor eliminating risk factors associated with Syndrome X in a subject through the cinnamon extrac. The cinnamon extract supplement is administered orally, intravenously or subcutaneously. Inone embodiment, a daily dose of 10-1,000 mg of the cinson extract supplement is administered tothe subject for a period ‘of 6 weeks to 6 mont, dinistation of thePatent Application Publication Aug. 23,2007. Sheet 1 of 2 Fig. 1 US 2007/0196520 AI Persons expressing interest in study (n=30) Screened for participation and randomiy assigned (a=22) Placebo group Cinnulin group (n= 10) (n= 12) Withdrew Withdrew (n=0) (n=1@wk6) | Analyzed * Analyzed (a= 10) (n= 12)Patent Application Publication Aug. 23,2007. Sheet 2 of 2 Fig.2 US 2007/0196520 AI unit change (post-pre) babwonnow FBG (mg/dL) | SBP (mm Hg) Lean Mass (kg) [ACinnutin 9.8 46 0.6 Placebo 44 82 08 [P-value 0.01 0.001 0.02 0,002US 2007/0196520 AI METHODS AND MATERIALS FOR REDUCING OR ELIMINATING RISK EACTORS ASSOCIATED WITH SYNDROME X REPERENCE TO RELATED APPLICATIONS [0001] This application is a coatinuation-in-par of US. patont application Ser. No. 101908142, fled Dee. 17, 2004, Which elsims priority of U.S, Provisional Patent Application Ser. No, 60/521,157 filed Mar. 1, 2004 FIELD OF THE INVENTION [0002] ‘The present invention generally relates to the use of ‘cinnamon extract as a preventive, alleviative or remedy for reducing risk factors associated with Syndrome X, and in paricular © reducing systolic blood pressure, fasting blood ‘lucose, or hody mass index in a subjet with Syndrome X BACKGROUND OF THE INVENTION [0003] Syndrome X is a metabolic disease characterized by the presence of several of the following risk factors hyperulycemia, hypertension, low high-density lipoprotein (HDL), high low-density lipoprotein (LDL), high triglycer ‘de, and abnormal body miss index (BMI), mier0-albumin- Uuria, endothelial dysfunction, prothrombotic state, and inflammatory process, Although not ll these eiteria need t0 be met before a diagnosis of the disease may be found. In fact, three occurrences of these symptoms may be found indicative of the disease [0004] It is estimated that over 22% of the adult US. population have Syndrome X and the incidence is rapidly Increasing each year, Old age, postmenopausal status, et- icity, higher body mass index, current smoking, low house- hhokd income, high carbohydrate intake, and physical inae- tivity all ave been connected with the increased ods of the ‘onset and or deterioration of Syndrome X. An adktional 12 milion adults will ikely develop the disease as a result of aging alone by 2022. [0005] Not a single cause at the molecular level can be teaoed © the origin of Syndrome X. However, increasing ‘evidence suggests the disease originates from both insulin resistance and setivaton of vascular inflammatory mechs- nisms related t0 increased oxidative sess. For example, insulin resistance results in preferential metabolism of free fatty acids which leads to reiueed glucose utilization. Insi- sistance is idemtiied in children prior to the develop- ment of the dyslipidemia, hyperteasion and hyperglycemia that occur later in Tite. As one ayes, pancreatic beta cell ‘exhaustion is not able to meet insulin resistance demands, and this might eventually lead (0 the progression of meta bolie distance inclading dyslipidemia, hypertension, etc ‘On the other hand, the infiltration of adipose tissue by inflammatory macrophages has been indicated as # common feature of obesity. Adipose mass as measured by weight, BMI or viseeral obesity correlates quantitatively with tenete expression of macrophages that produce inflamma- Tory mediators and markers, Therefore, While Syndrome X may’ share some characteristic feamres with diabetes, itis nota dihetie or pre-diabetic condition per se. Other distinct factors and causes are also involved. [0006] Allin all the treatment for Syndrome X varies realy. Many times, a person diagnosed with several risk Aug. 23, 2007 actors as discussed above would be prescribed a low Fat dict, exercise regime, and pharmaceutical intervention including a host of drugs to inlvidually combat issues with cholesterol, blood pressure, glucose, and body weight. Due to the complicated nature of such therapy, offen times compliance is rather low. [0007] Cinnamon is known in the art forthe eoutrol of blood ghicose. Broadhurst ta, demonstrated that cinnamon isa strong potentiator of insulin in comparison to various other herbs and spices (J. Agric. Food Chem., 2000; 48:849- '852). Researchers have demonstrated that cinnamon’ gh- cose-lowering ellcts are from a class of compounds other than chromium. One study by Kahn et al. compared the chromium levels of foods and spices including cinnamon, ‘and fied to finda correlation between chromium level and the level of insulin potentiation (Biological Trace Element Research, 1990; 24; 183-188). meta-analysis by Althuis t al. showed ao association between chromium and ghicose oF ‘insulin concentration (Am. J. Clin. Nute, 2002; 76: 148-55). [0008] One such compound of the cinnamon extract, ‘methyIhycroxyetaleone polymer (MECP), is shown to be particularly effective for glucose contml. A recent study ‘compared the effet of MICP in 3T3-L1 adipocytes to that of insulin Garill-Taylor et al; J. Am. College Note 2001;202327-336). The results Irom that study support the theory that MHCP triggers the insulin cascade anid subse- quent tensport of nutrients. The study also demonstrated that MLICP treatment stimulates glucose uptake and glyeo- gen synthesis toa similar level as insulin, The study further ‘demonstrated that treatment with endogenous insilia and ‘MIICP resulted in a synergistic effect. Due to the in vito ‘nature of this study, any potential effect by MHICP on blood pressure or lean body mass or serum lipid profile in an Jndividual could aot be demonstrated. [0009] In a more recent study by Khan etal. (Diabetes Care, 2003, 26, 3215-3218), type II diabetes patients were ‘ound t have their glucose and lipid profile improved ater cinnamon intake, These patieals were of age 40 aad above with glucose levels in the range of 140-400 mg/d. Daily {rvaiment with cinnamon reduced fasting phneose levels by 18-20% inthese patients, as well as triglycerides by 23-30% ‘and LDL by 7-27%, Its note that these patient were “very iabetic™ when recruited for the study. Although rendered “Tess diabetic” after the cinnamon treatment, these patient were stil) diabetic with abnormally high blood glucose levels, So it remains to be detennined whether the rae cinnamon regime as preseribed in this study souk! be effective to reverse these patients’ glucose level from an fbnormal sate ta normal state, as defined by NCEP-ATP- IIL In addition, another important biomedical parameter, Jean body mass, was not examined in tis study [0010] Therefore, snd in view ofthe fet that Syndrome X is distinguishable in cause and effect from diabetes, these rior at disclosures do not tach a teataient for pathological States such as hypertension and hyperglycemia in subjects ‘who are not already diabetic: nor do they suppoet a method to concurrently reduce and improve three or more risk ‘actors associated with the Syndrome X even in diabetic subjects. Furthermore, these prior art documents fail 10 provide a useful teaching on how to eliminate a risk factor fr reverse a disease stat, for example, to render the subject {rom being diabetie to non-diabetic.US 2007/0196520 AI [0011] To date, the prior art has not provided any thera peutic materials which can specifically address Syndrome X. Heretofore, therapies have been directed to the eeatment of specific features of the syndrome on an individual basis, and not to any holistic therapy. As willbe explained in deal, the present invention recognizes that particular cingamoa-de- Fived materials are effective in simoltancously controlling multiple pathologies of Syadrome X. Furthemore, the therapeutic materials and methods hereof ate simple implement and conducive to good patient compliance, SUMMARY OF THE INVENTION [0012] The present invention relates 1 @ composition ‘containing a cinnamon extract and a method of using the ‘composition 10 prevent, alleviate, and treat risk factors associated with Syndrome X in a subject. In particule instances, the subject is non-diabetic, and in certain instances the subject is pre-diabetc. In Some instances the ‘composition contains a known coneentration ofa least one ‘etive component sich as a polyphenol BRIEF DESCRIPTION OF THE DRAWINGS [0013] FIG. 1 depicts a Nowehar for the study examining ‘effets of a water-soluble cinnamon extract on features ofthe Syndrome X in pre-diabeie men and women, [0014] FIG. 2 shows the significance of FBG, SBP, % fa sand lean mass changes elicited from subjects who have been ‘upplemeated with the water-soluble eisnamon exact. DETAILED DESCRIPTION OF TIE INVENTION [0015] “Risk factor” isa pathological disorder that con- Ieures tothe formation ofa diagnostic Syndrome X. [0016] “Polypheao!” refers to a group of chemical sub- stances found in plants, characterized by the presence of ‘more than one phenol group per molecule. Research indi ‘cles that a class of polyphenl has antioxidant character- Jstes with potential leah benefits, Sourees of polyphenols Include green tea, white tea, red wine, dark chocolate, olive oil, and other futs, vegetables, and pants including cinnae [0017] “Chaleone” refers to an aromatic ketone that forms the central core for a variety of important biological eo pounds, which are known collectively as chalcones. They show antibacterial, anti-fungal, anti-tumor and ant-inflam- matory properties. They are also intermediates in the bio- synthesis of lavonoids [0018] “MECP™ represents methyl hydroxy! chaleone polymer and is found in einnamon, [0019] “Polyphenol Type-A polymers” are the bioactive type of polymers in the cinnamon extract. Tey aro identi fied by ther protonated molecular masses as A type doubly Tinked procyanidin oligomers of the estechins and/or epi ‘catechins, The polymers are composed of moaomerie unis [0020] “Reducing” a risk factor relates to a statistically Significant change with p-valuo140 mmilg and a diastolic blood pressure (DBP}>90 mmtig or >130/80 mmffg in subjects with Syndrome X. Hypertension increases the risk of atherosclerosis, periph- ‘eral avterial disease, chronic renal insuliceney, chronic renal failure, dementia and candiovascular mortality. Hyper tension may also find its association with prolonged insulin resistance In foc, insulin resistance allen precedes hyper tension by 10-20 years, Insulin resistance-induced hyper tension may involve the interplay of nitric oxide, MAPK pathway, and PISK pathway. On the other hand, vascular {inflammatory events also conteibate to hypertension, Loss af arterial compliance, distensibility and elastie modus dve to increased collagen and extracellular matrix ly the founda- tion for the occurence of hypertension. Hypertensive pallens with Syndrome X often require three 10 four aati hypertensive meslicatons 10 reach a blood pressure of 140) 90 mnie oF less, Lower recommended target blood pres- sure goals of 13080 mmHg or perhaps 11070 mmfig ‘cannot be achieved without aggressive use of balanced drug and non-drug treatments [0086] Yer another underlying etiology of Syndrome X, ‘dyslipidemia, i characterized as a collection of phenotypes that includes increase fee fatty acids, elevated serum tia- Iyorides, decreased HDL cholesteri, elevated LDL cho- lesterol. Low HDL cholesterol, with a shift to smaller size TDL, is common in Syndrome X and is due to triglyceride cearichment of HDL, increased HDL. degradation by hepatic, Fipase and inereased apoliprotein AI catabolism. A then- peutic strateyy for dyslipidemia treatment should be t0 Feduce LDL. cholestera to 60-70 mg/dL, increase HDL ‘cholesterol 0 40 igi. ia men and SO mg/dl in women, and to reduce triglyceride levels to ess than 150 mald.. Appro- priate combinations of nutetional supplements aad lipid fowering drugs may work in canoer to help achieve these oals, Iris known inthe art that dietary supplements helpful ‘in reducing dyslipidemia associated symptoms include 3. marine lipids, policosano, plant sterols, soy, green te, flax, meotrienols, pantothenic acid, tc. [0087] One oF more risk factors are represented in each ‘underlying etiology associated with Syndrome X. These risk factor include, but are aot limited to, abnormalities ia systolic bloed presture (SBP), in fasting blood glacose (FBG), in boa high-density lipopro- ‘ein cholesterol, low-density lipoprotein cholesterol, serum triglycerides, ete. Conventionally, aeeording 0 National ‘Cholesterol Pétacation Program’s Adult Treatment Pane Il, ‘concurrent occurrences in abnormal SBP, FBG, and BMI are indicative ofa finding of Syndrome X in an individual. An abnormal SBP, FBG, or BMI inthe individual is defined as 8 value of SBP>=130 mmllg, of FEG>=110 ml, [0088] Cinnamon extract materials are metabolized in the ‘individual to yield a therapeutically effect amount of com- pound species, namely cinnamon polyphenol, cinnamas Aug. 23, 2007 +, cinnamon catechin or epicatechin, cinnamon cal- ‘enc, and cinnamon MHICP. MEICP has been discovered to stimulate glucose uptake by facilitating glyeogen produe- tion, In particular therapies, each dose of the cinnamon cexteact supplement is selected 80 a8 to deliver into the individual MLICP ia the amount of 10-30 milligrams (mg). A method of treatment includes administering a theeapeu cally effective amount of an iaventive cinnamon extract supplement to an individual with @ manifestation of Syn- rome X. [0085] Variable dosing regiments are operative in the ‘method of treatment. While in some instances, a single dose treatment is effective in producing therapeutic elects, in other instances trent period inthe range of 6 weeks to 3 months is wilized [0060] The supplement can be administred orally: paren- fall, such as intravenously; by intramuscular injections by intraperitoneal injetion; or tansdermally. The exact dose of the supplement required can vary from subject to subject, depending. on the age, weight, general condition of the subject, the severity of risk factors associated with Sya- drome X, the mode of administration, and the like. An appropriate dose is readily determined by one of ordinary slalls in the art using oly routine experimentation given the teachings herein. Generally, dosage is in the range of 10 000 mig of equivalent of dry cinnamon powder per day. [0061] Parenteral administration i generally by injection Injectbles ean be prepared in conventional forms, either liquid solutions or suspensions, solid forms suitable for solution oF priar to injection, oF a8 suspension i liquid prior {0 injection or as emulsions [0062] ‘The example presented below is intended to illus- {rate & particular embodiment of the invention and is not intended o limit the scope ofthe specification including the claims, i any way. EXAMPLE [0063] |The effet of supplementation with a water-soluble ‘innamon extmet (Cianulia PPTM) on features of Syndrome x. Experiment Design [0064] This study was a randomized, placcho-conteolled ‘double-blind clinical wil with two parallel groups. Seram chemistry, body weight, and body composition were mea- sured at baseline and atthe end ofthe 13-week supplemen- {ation period. Subjects also completed 3-day food records And had measurements of their systolie and diastolic blood pressures during pre (weck 0), mid (week 6). and post (Weck 12) testing. FIG. | presents the lw of participants through tie study 5) Subjects [0065] Subjects were recruited from northeastem Ohio, a ‘ypical suburban region, by wor! of mouth and posted announcements. Thirty (30) potential participants aged 30-60 years were interviewed by telephone, OF these, 22 ‘were invited for a preliminary sereening consisting of height, weight, blood pressure, and a fasting blood sample Subjects were required to have FBG between 100 mel (66 mmol/L) and 125 mpldL. (69 =moVL), have normalUS 2007/0196520 AI values for liver and kidney function tests, and be willing t© maintain their usual dietary and physical activity habits Subjects were excluded from the study i they had a body mass index (BMI) >40 kgm, thyroid disease, hypopo- nadism, a history of musculoskeletal, autoimmune, or nev- rologic disease, or if they were currently taking’ hyroi, hypedipidemic, hypoglycemic, antichypertensive, or anti- ‘coagulant medications. Prior to obtaining written, informed ‘consent from each subject, an institutional review board (lntegReview Ine, Austin, Tex.) approved the experimental protocol. All procedures in the study were in accord with ‘ethical standards set forth in the Helsinki Declaration of 1975 as revised in 1983, Supplementation [0066] After matching for age, FBG, SBP, and habitual physical activity levels, subjecis were assigned to a inna ‘mon extract material (Cinnulin PF) (n-12) or placebo (n=10) group. Bach subject was insiructed to tale two ‘capsules 250 mg) oftheir respective supplement wiee per slay (with breakfast and dinner). Aceording to the manufac turer, 500 mg of Cianulia PP i equivalent to approxi mately 10 g of whole cinnamon poweder (ic, 20:1 extract) ‘and contains atleast 1% doubly-linked polyphenol type-A. polymers (considered to be the bioaetive component), and -<0,001% coumaric acid and cinnamaldehyde. Supplements were prepared in a 2piece hard shell capsule form and packaged in coded generic containers for double-blind ‘administration by Integrity Nutraceuticals International (Saeasota, Fla), Medical monitoring and compliance to the supplementation protocol was supervised by a research technician who contacted the subjects on a weekly bass Each subject was roguired to ret the original bottle of their respective supplement for pill counts during mid (week 6) and post (week 12) testing. Heart Rate and Blood Pressure [0067] All subjects reported (0 the laboratory after a 12-hour fast and at least 48 hours aller participating in Jmense physical activity, Following ten minutes of seated rest, subjects’ heart rat and blood pressure were determined by palpation of the radial artery and aneroid sphygmoma- rnometry, espectvely. The same technician performed all measurements using standard procedures, i) Blood Collection and Analyses [0068] Immediately following blood pressure readings, approximately 20 ml. (~4 teaspoons) of blood was drawn ‘with stasis via venipuncture ofan antecubital vein. All blood, samples were taken in the moming st approximately the same time of day to minimize diumal variation, and subjects Used their baseline diet records to standanlize thei final (evening) meal before mid (week 6) and post (week 12) testing [0069] Blood samples were harvested into tubes with and ‘without EDTA, centrifayed tracker model 614, Philipsburg, a.) at room temperature for 15 minutes at 1200 to obtain plasma and serum, and immediately placed into 160 ‘quots. One aliguot was immediately analyzed for ® 2T-item 0.98. v) Diet and Physical Activity [0072] As mentioned previously, this study used a five- living design where subjects were advised to maintain their normal diet during the study. To verily this, subjects com- pleted 3d food records (which included two weekdays and ‘one weekend day) during baseline testing. week 6, and Week 12. All food records were analyzed by a licensed, registered ietitian using commercially available software (NutaBase IV Clinical Edition, AZ). To enhance sveuracy ofthe food records, all subjects received instruction during baseline testing on how to accurately estimate portion sizes. This counseling Was reinforoed during each Visit t the labor tory. No dietary supplements were allowed withthe excep- tion of standart strength multivitamins. [0073] _ Subjects were also advised 1 maintain thei current Jevel of habitual physical activity throughout the study. Physica aetvity levels were measured with the Framingham Physical Activity Index (Kannel W B, Sorc P Some health bene of physical ativity: The Framingham Heart Study. Arch. Inter. Med. 1979, 139:887-861) during. baseline testing, week 6, and week 12,US 2007/0196520 AI vi) Statistical Analyses [0074] Statistical analyses were conducted using Satstiew version 71 (Stat Soft Inc, Tulsa, Okla). Differences between groups at baseline were analyzed with independent tests and chi-square tests. Separate 242 or 233 (Groupx ‘Time) univariate ANOVA with repeated measures onthe Tat factor were used to analyze between uroup differences over time. Since a drop outdid occur in this study, intent-to-treat ‘analyses (ITT) were performed, using the las-ahservation= ‘eatied-forward method, Inan ITT approach, all sindomized Subject” data are included inthe data analysis, regardless of ‘whether they complete the tial or are compliant ith the procedures. In contrast, most studies on dietary supplements use a "per protocol” analysis and exelude noncompliant subjects or subjects who drop out. Although a discussion of ITT analyses is beyond the scope ofthis discussion, many researchers consider ITT io be the prefered method of data analysis in enical efficacy stdies as it's less prone to bias. ‘When significant interaction was observed, Fisher's Least Significant Differences (LSD) post-hoc test was performed. ‘When the interaetion term was “marginally signifiant” (i.e. (005110 mg/dl. (Cinaulin: 16213, Placebo, 112210), systolic BP>130 mm Hg (Cinnulin: 133214, Placebo: 133222) and tracylglyeero>180- mg/dl. (Cinnolin: 1662142, Placcho: 165=107). There were no significant differences in general, metabolic, or dietary characteristics between groups at baseline ABLE L Bie Cua of i Suits Reni fre Su nutes Tet oo, Panlue We tn, isms oust On BM Gai) Maras Big ee eat Ma bs) hosts 06 Syeic Rood Prseus fmm ile) 123222194 Duele ocd Pense mm i) SSE ASS ‘Fad Chanel mei) Tem asat On Aug. 23, 2007 Puree Test foe) (wet) Prat 4) Supplementation Compliance and Adverse Events [0076] Comptiance to the supplementation regimen was efined as thee number of eapsules actualy taken by each subject divided by the number of eapsles that should have beet taken aver the course of the sty. Fxelading one cop cout in the Cinnulin group, compliance was >97% in both ‘groups. Adverse events were based on spontaneous report- ing by subjects as well zs open-ended inguires by members ‘of the research staff, No adverse events were reported during iy HR anal BP. [0077] _Afer 12-vexks,subjets in the Cinnulin. group secede SBP by 3% om 1334 mm Fe] 1ak=18 mim He [post P<. 001) compared to subject Placebo group (rm 133222 mum Fp [pe] to 142220 mm eg [pon No between orwilingroup changes in diastolic blood pressure (Cinnulin: from 8326 mm Hz [pre] to 8429. at Hg [post]; Placebo rom 83214 a ig [ve] 0 812 tm Tig pst], P<032) or THR (Cinolit from 63314 beats/min [pre] to 69:12 beats/min [post]; Placebo: from ‘Tiats beatuimin [pe] to 7428 beatsnin [pont], Pel. 73) ‘were noted in eter group i) Blood Chemistry 0078] FIG. 2 presents changes in FBG during the study: Sobjects inthe Cinnalin group had significant decreases in PRG (88 fom 116-2128 mpl [pe] 106.5220 1 mydL. [post], P-<0.01) compared to subjects in the Placebo group (from 112.0210.0 mg/dL. [pre] to 113.1214.7 mg/dL [post]. No other between group effects were noted for BUN, ereaitine, bliin, alkaline phospiatase, AST (SGOT), ‘ALT (SGHD) sodium, ptstitm, eons. cfeiam, at ‘nia, globulin, CO, tt protein, eal choker, HDL-C, TLC, VLDI-C. or righoerdce and all values read ‘within normal clini mits (Table 2) TABLE 2 ‘Ses Hemasisl Ssones oo Suleman. fant) tant) (Gx _ nenaUS 2007/0196520 AI TABLE 2-continued Aug. 23, 2007 [post], Pc0.002), and decreased their body ft by 0.7% (fro 37.929.2% [pre] 0 37.288.9% [post within-group analy e002). No changes in lean miss (Irom 43.9=11.1 ky [pre] 0 43.1210.9 ky [post) or fat mass (Grom 43.828,0% [pre] to -44.229.0% [post)) were not the Plavebo group. Because the baseline Value for lean mass was marunally significant (P<0.06), wealso performed an ANCOVA using week Olean ‘mass as the covariate, Results confirmed that Tean mass at wweek-12 was significantly greater in the Cinnuin group (P0.004) [0080] _v) Diet and Physical Activity [0081] Table 3 presents totals for three-day dietary intake ‘obtained during the study. No changes in total daily enenay for macronutrient intake were noted during the study although there was a trend for subjects in the Cinnulin group {o consume more total Calories (P<0.07). Follow-up testing for within-group changes (via dependent est indicat subjects in the Cinnulin group ingested significantly more fotal energy during week-l2 (P<0.08). No changes in habitual physical activity oovured between groups over ‘ime (data not shown) TABL G21 Gait) eT) eral ‘sense (TUL) ‘noe 1) ee Chotetent(rgit) "oat anatge Pe mia wea “eye cas ona inet) Taleo tae Catone 3) mee Prati) Clot! oe) TABLE 2-continved Seles Hema Kesomes ts Suleman Pe Sie MER Yibu wea ee ae Mie Min otis Re Man SE EDLeagity bao Mi mis) gee Poe es tues §v) Body Composition. [0079] FIG. 2 presents changes in body composition dur. jing the study. Subject ia the Cianulin group increased Ui Jean mas by 1.1% ({rom $3.7211.8 kg [pre] 0 54.321 1.8 ka Tins Day Tol Day ke fhe Sie ‘Paco (| Pa gst) Cin pe) Cama get) (xT) [0082] The foregoing establishes that cinnamon extract smaterals of the type described herein can treat multiple symptoms associated! with Syndrome X, [0083] Any patents or publications. mentioned in this specification are herein ineorporated by reference 10 the same extent as if cach individual publication was speci cally and individually indicated to be incosporated by ref [0084] One skilled in the art will readily appreciate that the present invention is well adapted to eary out the objects fad obtain the ends and advantages meationed, a8 well as those inherent therein. The apparats and methods described herein are presently representative of preferred embodi- ‘ments, exemplary, and not intended as limitations on the scope ofthe invention. Changes therein and otber uses will ‘curt those skilled in the an. Such changes and other uses fan be made without departing from the scope of the invention as set forth in the claims. 1. A method for reducing a risk factor associated with ‘Syndrome X in a subject, where th subjet is prelabetic, jeomprising the sep of: ‘administering to said subject a therapeutically effective ‘amount of a eianaaon extUS 2007/0196520 AI 2, The method of claim 1, wherein the risk factor, as defined by NCEP-ATP-II, is Seleeted from the group con= sisting of abnormal systolic blood pressure, abnormal fast- ing blood glucose, abnormal body mass index, abnormal high-density lipoprotein, abnormal low-density lipoprowein, abnormal blood triglyceride 3. The method of elaim 1, wherein the therapeut celfective amount of a cinnamon extract is administered ‘orily; intravenously: by intramuscular injections by intra Peritoneal injection; and transdermal. 4. The method of claim 1, wherein the therapeutically ‘ellective amount of a cinnamon extect is administered ‘only in the form selevted from the group consisting of tablets, suppositories, pills eapsules, powders, liquids, sus- pensions '8, The method of elaim 1, wherein the therapeutically effective amount of @ cinnamon extract supplement com- prises a predetermined aout of polyphenol type-A poly- Aug. 23, 2007 6.4 method for eliminating a risk factor associated with Syndrome X in a subject comprising the sep of ‘administering wo said subject a therapeutically efeeive ‘amount ofa cinnamon extrac, 7. A method for concurrently reducing atleast three isk factors associated with Syndrome X in subject, comprising the step of, administering to said subject a therapeutically effective ‘amount of a cianamon extic 8. A compositon for teucing tsk fctor associated with Syndrome X ia a subject, comprising: 4 cinnamon extrt containing a known concentration of ‘at last one bioactive polymer contained thrsin, 9. The composition of clsim 8, wherein the bioactive polymer is polypienltype-A polyee 10. The composition of claim 8, wherein the bioative polymer is MCD