Patent Abstract:
in one embodiment , a method is provided for lowering c - reactive protein levels in a mammal . the method comprises administering a composition containing an effective amount of irvingia gabonensis seed to a mammal to reduce c - reactive protein levels in the mammal . other embodiments include , among other things , lowering leptin levels , increasing adiponectin levels , reducing body weight , decreasing ldl and total cholesterol levels , increasing fat loss , and reducing waist size in a mammal using administering a composition containing an effective amount of irvingia gabonensis .

Detailed Description:
participants ( age 19 - 50 ) were recruited from the global population of the city of yaoundé , cameroon through radio advertisements and posters . inclusion criteria included : ( 1 ) being a basically healthy person ; ( 2 ) not having a current / recent cold or flu ; ( 3 ) having a bmi between 26 kg / m 2 and 40 kg / m 2 ; ( 4 ) not following any particular dietary regimen ; ( 5 ) not currently following a weight loss program ( 6 ) being a non - smoker ; ( 7 ) able to cope with multiple blood sampling ; and ( 8 ) willingness to sign the consent form . based on the above criteria , 102 persons were selected to participate in an information session in which the nature , purpose , and potential risks of the study were clearly explained . all participants gave their written informed consent before the study began . the protocol was approved by the cameroon national ethics committee ; the study was conducted in accord with the helsinki declaration ( 1983 version ). the study was a randomized , double - blind , placebo - controlled design . the 102 west african participants were randomly divided into two groups : placebo ( n = 50 ); igob131 ( n = 52 ). the demographics for the two groups were very similar . five subjects in the placebo group versus six subjects in the treatment group had a family history of diabetes . one subject in the placebo group versus three in the treatment group had a history of gestational diabetes . body weight , body fat percentage , and waist size were also monitored at the same time . no major dietary changes or physical exercises were suggested during the course of the study . all test materials were supplied by gateway health alliances , inc . ( fairfield , calif ., usa ) in individual packets of capsules . the identical - looking placebo and active formulation capsules contained , respectively , a maize - based powder consisting of 150 mg starch , or a maize - based powder containing 150 mg igob131 . the participants consumed either one capsule of placebo or igob131 twice daily before meals . fasting blood samples ( 5 ml of blood ) were collected at baseline , and at four , eight , and ten weeks after product administration . blood collection was performed by means of venipuncture coupled to vacutainer tubes . the serum was prepared after blood centrifugation , split into 500 pl aliquots and stored at − 20 degrees c . until needed to assess changes in the biochemical parameters ; i . e ., blood cholesterol , fasting blood glucose , c - reactive protein , adiponectin , and serum leptin . anthropometric measurements ( body weight , percent body fat , and waist circumference were assessed using a tanita ™ bc - 418 segmental body composition analyzer / scale that uses bio - electrical impedance analysis for body composition analysis . height was measured with a standard tape measure affixed to a wall while the subject stood on a level , hard surface . hip and waist measures were obtained with a flexible tape measure , without restrictive garments , to the nearest 0 . 1 cm . waist circumference was measured mid - point between the bottom rib and hip bone , taking care to keep the tape in contact with the curve of the back . hip circumference was obtained at the widest point of the hip . participants were measured at approximately the same time of day each visit to ensure consistent results . serum total cholesterol was assayed using the cholesterol oxidase method , ( richmond , 1973 ) while triglycerides were determined using the method described by buccolo and david ( 1973 ), serum glucose was measured enzymatically ( trinder , 1969 ). quantitative determinations of c - reactive protein ( crp ) were determined in duplicate using a high sensitivity immunoassay ( oxis international , foster city , calif . usa ). serum leptin was determined in duplicate using an enzyme - linked immunosorbent assay ( elisa ) ( diagnostic systems laboratory , webster , tex . usa ). all samples were run in the same assay with an intra - assay variance of 3 . 2 %. serum adiponectin was determined in duplicate using an enzyme immunoassay ( aplco diagnostics , salem , n . h . usa ). all samples for each hormone were determined in the same assay to avoid inter - assay variance . assay intra - assay variance was ≦ 5 %. the data for each parameter was summarized ( n , mean , and standard deviation ) for week zero ( initial ) and weeks four , eight , and ten , and for the intra - group percent differences ( initial versus weeks four , eight , and ten ). several measurements were made for each parameter . the percent change from baseline was tested for differences using the mixed effects mode — a flexible tool for analyzing longitudinal and repeated treatments . statistical package for the social sciences ( spss ) software was used for all statistical analysis . the igob131 ( versus placebo ) group showed a significant decrease in all three variables by week four , with the magnitude of the differences continuing to increase throughout the trial period . by week ten , the differences in measures of body weight , body fat percentage , and waist size between the treatment and placebo groups were all statistically significant at the p & lt ; 0 . 01 level ( tables 1 , 2 , 3 ). after four weeks of treatment , the placebo group lost 0 . 6 kg compared to the igob131 group , which lost 3 . 6 kg ( 3 . 7 %). to translate the difference in amounts lost to final outcomes , the ten - week mean body weight of the placebo group was 95 . 7 kg versus 85 . 1 kg for the treatment group ( p & lt ; 0 . 01 ). in terms of intra - group mean percent change in body weight from baseline to ten weeks , the placebo and treatment groups lost 0 . 7 % and 13 . 1 % ( p & lt ; 0 . 01 ), respectively . as was true of body weight , the placebo group showed no significant change ( 1 . 4 %) in %- body fat after 4 weeks compared to the igob131 group , which lost 2 . 6 %- body fat ( a 7 . 49 % reduction ). to translate the difference in amount lost to final outcomes , the ten - week mean body fat percentage of the placebo group was 32 . 7 % versus 27 . 9 % for the treatment group ( p & lt ; 0 . 05 ). in terms of intra - group mean percent change from baseline to ten weeks , the placebo and treatment groups lost 5 . 7 % and 18 . 4 % ( p & lt ; 0 . 05 ), respectively . waist circumference appears to be one of the most important determinants in the diagnosis of metabolic syndrome and obesity . although the placebo group showed a 3 . 7 cm decrease after four weeks , the igob131 group lost 7 . 1 cm . by week ten , the 5 . 3 cm reduction in waist size for the placebo group was less than one - third the 17 . 0 cm reduction shown by the treatment group ( p & lt ; 0 . 01 ). in terms of intra - group mean percent change in waist size from baseline to ten weeks , the placebo and treatment groups lost 5 . 0 % and 16 . 2 % ( p & lt ; 0 . 01 ). as shown in tables 4 , 5 , and 6 , the igob131 treatment ( versus placebo ) group showed a large decrease in these three variables by week four . as with the three anthropomorphic variables ( see above ), the magnitude of the losses continued to increase throughout the entire ten - week trial period . in contrast to the small ( 1 . 34 mg / dl ) decrease shown by the placebo group , by week four the reduction for the igob131 group was 18 . 0 mg / dl ( 11 . 9 %). to translate the difference in the amounts of decrease to final outcomes , the ten - week mean total cholesterol level of the placebo group was 142 . 5 mg / dl versus 111 . 9 mg / dl for the treatment group ( p & lt ; 0 . 05 ). in terms of intra - group mean percent change from baseline to ten weeks , the decreases made by the placebo and treatment groups were 1 . 9 % versus 26 . 2 % ( p & lt ; 0 . 05 ). again , in contrast to the small ( 0 . 96 mg / dl ) decrease in ldl shown by the placebo group , by week four the reduction for the igob131 group was 10 . 4 mg / dl ( 12 . 6 . 0 %). to translate the difference in the amounts decreased to final outcomes , the ten - week mean ldl cholesterol level of the placebo group was 4 . 8 mg / dl versus 27 . 30 mg / dl for the treatment group ( p & lt ; 0 . 05 ). in terms of intra - group mean percent change from baseline to ten weeks , the decreases made by the placebo and treatment groups were 4 . 8 % versus 27 . 30 % ( p & lt ; 0 . 01 ). as with the measures of cholesterol levels ( above ), the small ( 1 . 9 mg / dl ) decrease in blood glucose level shown by the placebo group by week four can be contrasted with the large 8 . 91 mg / dl decrease ( 10 . 4 %) shown by the igob131 group . to translate the difference in amounts decreased to final outcomes , the ten - week mean blood glucose level of the placebo group was 77 . 1 mg / dl versus 66 . 3 mg / dl for the treatment group ( p & lt ; 0 . 05 ). in terms of intra - group mean percent change from baseline to ten weeks , the decreases made by the placebo and treatment groups were 5 . 3 % versus 22 . 5 % ( p & lt ; 0 . 05 ). as shown in tables 7 , 8 , and 9 , the igob131 treatment ( versus placebo ) group showed large changes in these three variables by week four . the magnitude of the changes increased through week eight and remained constant through week ten . in contrast to the minimal ( 0 . 017 mg / dl ) decrease shown by the placebo group through the entire trial period , by week four the reduction for the igob131 group was 0 . 58 mg / dl ( 38 . 9 %). to translate the difference in the amounts of decrease to final outcomes , the ten - week mean c - reactive protein level of the placebo group was 1 . 445 mg / dl versus 0 . 715 mg / dl for the treatment group ( p & lt ; 0 . 01 ). in terms of intra - group mean percent change from baseline to ten weeks , the decreases made by the placebo and treatment groups were 1 . 2 % versus 52 . 0 % ( p & lt ; 0 . 01 ). in contrast to the small ( 1 . 83 mg / i ) increase in adiponectin levels shown by the placebo group , by week four the increase for the igob131 group was 12 . 7 mg / dl ( 104 . 3 %). to translate the difference in the amounts increased to final outcomes , the ten - week mean adiponectin level of the placebo group was 14 . 9 mg / dl versus 31 . 6 mg / dl for the treatment group ( p & lt ; 0 . 05 ). in terms of intra - group mean percent change from baseline to ten weeks , the increases made by the placebo and treatment groups were 23 . 4 % versus 159 . 8 % ( p & lt ; 0 . 05 ). the small ( 2 . 0 ng / ml ) decrease in blood leptin levels shown by the placebo group by week four can be contrasted with the large 14 . 8 ng / ml decrease ( 45 . 0 %) shown by the igob131 group . to translate the difference in amounts decreased to final outcomes , the ten - week mean leptin level of the placebo group was 28 . 4 ng / ml versus 16 . 9 mg / dl for the treatment group ( p & lt ; 0 . 01 ). in terms of intra - group mean percent change from baseline to ten weeks , the decreases made by the placebo and treatment groups were 9 . 4 % versus 48 . 7 % ( p & lt ; 0 . 01 ). adverse events with an incidence & gt ; 3 included headache ( 5 ), lack of sleep ( 6 ), and gas ( 6 ). since the incidence of all reported side effects was observed in the placebo group as well as in the treatment group , it is probably safe to conclude that the igob131 formulation had few , if any , negative side effects . a variety of naturally occurring plant extracts appear to have beneficial effects on animal and human health . some compounds have attracted considerable attention due to the cumulative evidence of their physiological qualities serving as anti - obesity and anti - diabetic agents , as well as their relative safety ( bhathena et velasquez , 2002 ). in accordance with this trend , the present study showed that one of these compounds , the igob131 extract , safely and significantly ( versus placebo ) reduced body weight and visceral fat mass , as well as plasma total and ldl - cholesterol concentrations . the igob131 treatment group also showed an increase in plasma adinopectin level and decreases in leptin and crp levels compared to the placebo group . insulin resistance is the hallmark of the metabolic syndrome and is strongly associated with excess adiposity ( kahn et flier , 2000 ; maison et al ., 2001 ). a variety of adipocyte - derived biologically active molecules termed “ adipocytokines ” have been identified , including leptin , resistin , tnf - α , and il - 6 , that may contribute to obesity - linked metabolic abnormalities ( kern et ranganathan , 2001 ; mcternan et al ., 2002 ). since plasma leptin level is closely correlated with the weight of adipose tissue ( friedman et halaas , 1998 ), and reports ( uygun et al . 2000 ) state that a continuous weight gain may result in increased serum leptin , the decreased plasma leptin level associated with igob131 treatment may be attributable to the decrease of adipose tissue induced as a consequence of weight loss . adipose tissue plays a prominent role in both insulin resistance and the clinical expression of metabolic syndrome , most likely mediated by the increased release and peripheral tissue action of non - esterified fatty acid and by the dysregulated production of adipocyte - secreted proteins , including leptin , adiponectin , resistin , tnf - α , and il - 6 ( hotamisligil et spiegelman , 1994 , matsuzawa et al ., 1999 , mcternan et al ., 2002 ). adiponectin , which is exclusively expressed in adipose tissue and abundant in human plasma , appears to be decreased in individuals with obesity , type 2 diabetes , and coronary heart disease ( weyer et al ., 2002 ; kumada et al ., 2003 ). although its physiological role is still unclear , adiponectin may possess insulin - sensitizing , as well as anti - inflammatory and anti - atherogenic properties ( okamoto et al ., 2000 ; yamauchi et al ., 2001 ; okamoto et al ., 2002 ; matsuzawa et al ., 2002 ). adiponectin has recently been shown to increase hepatic insulin sensitivity ( combs et al ., 2001 ), to stimulate fatty acid oxidation in liver and skeletal muscle , and to have protective effects on cardiovascular functions ( hu et al ., 1996 ; yamauchi et al ., 2001 ). there are several reports suggesting that adiponectin directly modulates glucose tolerance and peripheral tissue insulin sensitivity , possibly through amp kinase activation ( yamauchi et al ., 2002 ; tomas et al ., 2002 ). moreover , different modalities of weight loss — as well as peroxisome proliferator - activated receptor - γ ( ppar - γ ) agonist therapy — have been shown to increase adiponectin levels longitudinally ( yang et al ., 2001 ; yu et al ., 2002 ). another study demonstrated that moderate acute weight loss of 5 - 7 % in obese subjects with metabolic syndrome is associated with dramatic improvement in all aspects of the condition , although the individuals remained markedly obese ( case et al ., 2002 ). the study , which specifically assessed , among other things , adipocytokine variations in a group of obese subjects with metabolic syndrome after a ten week igob131 treatment , showed a marked improvement in glucose associated with a significant change in adiponectin levels . in general , expression of adiponectin in plasma correlates well with expression in adipose tissue . the study also measured the anti - metabolic syndrome effects of igob131 via body weight , abdominal fat mass , plasma lipids , adiponectin , c - reactive proteins , and leptin levels in obese participants . the extract &# 39 ; s efficacy may be a result of the synergistic effects of combining dietary fiber , albumin proteins , and antioxidants in sufficient amounts . the involvement of the soluble fiber fraction with an unstirred water layer present along the luminal surface of mucosa intestinal cells increases the thickness of that layer , thereby forming a physical barrier to the cholesterol absorption ( kritchevsky , 1988 ; roberfroid , 1993 ). the effectiveness of the igob131 extract may also be attributed to the albumin fraction . earlier human studies on the effect of plant protein revealed that the administration of soy protein to female volunteers with normal lipids levels induced a significant reduction in serum levels of blood lipids . a 1981 study ( wolfe et al ., 1981 ) showed a reduction of both total cholesterol and triglycerides levels in a hypercholesterolemic man who was fed a plant protein diet . other studies , similar to the plant albumin ones , have shown the metabolic syndrome - preventive activity of antioxidant components ( i . e ., vitamin c , polyphenols ). antioxidants , especially epigallocatechin gallate , had antiobesity activity and apparently improved metabolic disorders via modulation of adipokines and growth factors ( kao et al ., 2000 ; ashida et al ., 2004 ), especially suppression of leptin concentrations ( kao et al ., 2000 ; ashida et al ., 2004 ; sayama et al ., 2000 ). in sum , irvingia gabonensis extract ( igob131 ) administered twice a day to healthy , overweight , and obese individuals resulted in weight reduction ( body weight , body fat , waist size ) and an improvement in the symptoms associated with metabolic syndrome . the extract showed efficacy in the control and lowering of serum total cholesterol , ldl - cholesterol , and serum leptin levels , while the serum adiponectin was higher than in the placebo group . these results suggest that igob131 may be used to manage metabolic syndrome through control of obesity and lipid profile . 1 . sobngwi , e ., mbanya , j . c ., unwin n . c ., et al . 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