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Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

ABSTRACT: BACKGROUND:The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo. METHOD:115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an increased daily physical activity (7 MET-h/week). They were randomized to receive standard treatment plus placebo (ST?+?PL) or standard treatment plus polyglucosamine (ST?+?PG), respectively. Participants were instructed to take 2 × 2 tablets before the two meals containing the highest fat content for at least 24 weeks. Body weight, BMI, waist circumference and the time needed for a 5 % body weight reduction (5R) were taken as main variables. RESULTS:The average weight loss over a period of 25 weeks in the ITT population was 5.8?±?4.09 kg in the ST?+?PG group versus 4.0?±?2.94 kg in the ST?+?PL (pU?=?0.023; pt?=?0.010). After 25 weeks, 34 participants achieved 5R in the ST?+?PG group (64.1 %) compared to only 23 participants in the ST?+?PL group (42.6 %) (ITT) (p Fisher?=?0.033). Weight loss through hypo-caloric diets have been found to be effective. The additional effect of PG in combination with standard treatment is able to produce significantly better weight loss than placebo. CONCLUSIONS:Participants treated with ST?+?PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST?+?PL. TRIAL REGISTRATION:Trial Registration at ClinicalTrials.gov: NCT02410785 Registered 07 April 2015.

SUBMITTER: Pokhis K

PROVIDER: S-EPMC4511026 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

Pokhis Karina K Bitterlich Norman N Cornelli Umberto U Cassano Giuseppina G

BMC obesity 20150610

<h4>Background</h4>The purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo.<h4>Method</h4>115 participants were included in the study. We used a two-center randomized, double blind, placebo-controlled design. The participants followed a standard treatment (ST), which included the combination of a low-calorie diet achieved through creating a daily calorie deficit (500 cal) and an inc ...[more]

PMID: 26217540

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Project description:BackgroundVitamin D deficiency is associated with obesity; whether repletion supports weight loss and changes obesity-related biomarkers is unknown.ObjectiveWe compared 12 mo of vitamin D3 supplementation with placebo on weight, body composition, insulin, and C-reactive protein (CRP) in postmenopausal women in a weight-loss intervention.DesignA total of 218 overweight/obese women (50-75 y of age) with serum 25-hydroxyvitamin D [25(OH)D] ≥10 ng/mL but <32 ng/mL were randomly assigned to weight loss + 2000 IU oral vitamin D3/d or weight loss + daily placebo. The weight-loss intervention included a reduced-calorie diet (10% weight loss goal) and 225 min/wk of moderate-to-vigorous aerobic activity. Mean 12-mo changes in weight, body composition, serum insulin, CRP, and 25(OH)D were compared between groups (intent-to-treat) by using generalized estimating equations.ResultsA total of 86% of participants completed the 12-mo measurements. The mean (95% CI) change in 25(OH)D was 13.6 (11.6, 15.4) ng/mL in the vitamin D3 arm compared with -1.3 (-2.6, -0.3) ng/mL in the placebo arm (P < 0.0001). Changes in weight [-7.1 (-8.7, -5.7) compared with -7.4 (-8.1, -5.4) kg], body mass index (in kg/m(2): both -2.8), waist circumference [-4.9 (-6.7, -2.9) compared with -4.5 (-5.6, -2.6) cm], percentage body fat [-4.1 (-4.9, -2.9) compared with -3.5 (-4.5, -2.5)], trunk fat [-4.1 (-4.7, -3.0) compared with -3.7 (-4.3, -2.9) kg], insulin [-2.5 (-3.4, -1.7) compared with -2.4 (-3.3, -1.4) μU/mL], and CRP [-0.9 (-1.2, -0.6) compared with -0.79 (-0.9, -0.4) mg/L] [corrected] were similar between groups (all P > 0.05). Compared with women who achieved 25(OH)D <32 ng/mL, women randomly assigned to vitamin D who became replete (ie, 25(OH)D ≥32 ng/mL) lost more weight [-8.8 (-11.1, -6.9) compared with -5.6 (-7.2, -5.0) kg; P = 0.05], waist circumference [-6.6 (-9.3, -4.3) compared with -2.5 (-4.6, -2.0) cm; P = 0.02], and percentage body fat [-4.7 (-6.1, -3.5) compared with -2.6 (-3.9, -2.2); P = 0.04]. Among women with complete pill counts (97% adherence), the mean decrease in CRP was 1.18 mg/mL (46%) in the vitamin D arm compared with 0.46 mg/mL (25%) in the placebo arm (P = 0.03).ConclusionsVitamin D3 supplementation during weight loss did not increase weight loss or associated factors compared with placebo; however, women who became replete experienced greater improvements. This trial was registered at clinicaltrials.gov as NCT01240213.

Project description:BackgroundConversional bariatric surgery inherently has less weight loss (WL) compared to primary procedures. Adjunctive use of the GLP-1 analog, liraglutide with conversional Roux-en-Y Gastric Bypass (cRYGB) may maximize the WL benefits of surgery.Material and methodsThis single-center randomized double-blind placebo-controlled trial included 80 patients randomized into two groups; the liraglutide group (40 patients) who received daily injections of liraglutide, and the placebo group (40 patients) who received normal saline starting at 6 weeks from cRYGB and continued for 6 months. After discontinuing the drugs at 6 months and unblinding, the patient were followed up to 12 months. The endpoints were percentage of total weight loss (%TWL) and percentage of excess weight loss (%EWL), and changes in the metabolic biomarkers, and complications within 30 and 90 days according to the global outcome benchmark (GOB) stratification.ResultsIn total, 38 patients in the liraglutide group and 31 in the placebo group completed the 24 weeks. Liraglutide group experienced better WL with a significantly higher mean %TWL at 1 month (10.27±1.39 vs. 8.41±2.08), at 6 weeks (12.65±1.77 vs. 10.47±2.23), at 6 months (18.29 ±1.74 vs. 15.58 ±1.65), and at 12 months 24.15±2.35 versus 22.70±2.13 (all P <0.001). For %EWL, this was also significantly higher in the liraglutide group at all time points. A %TWL of greater than 20% at 6 months of treatment was recorded in six (15.8%) patients in the liraglutide group and none in the placebo group ( P =0.029). Both groups had comparable changes in metabolic biomarkers. Adverse events were recorded in 11 (27.5%) patients in the liraglutide, with no adverse events in the placebo group ( P <0.001). Both groups had Clavien-Dindo scores I and II (5.0 and 2.5%), and GOB values indicated that 90.0 and 97.5% were low-risk patients.ConclusionAdjunctive use of liraglutide with cRYGB gives significantly higher WL and resolution of associated medical problems.

Project description:Abstract Objectives To determine if greater weight loss and improvement in metabolic outcomes could be achieved with twice daily consumption of a proprietary supplement shake containing high protein and fiber (HPF) as compared to an isocaloric low protein, lower fiber placebo (P). Methods In an independently conducted randomized, double-blind, placebo-controlled, multi-center clinical trial, healthy overweight and obese adults (n = 206, BMI 27–35 kg/m2, 70% Female) were equally assigned to HPF or P. All participants were instructed to follow a 500-calorie deficit diet from estimated daily energy requirements using a dietary exchange program and were asked to consume HPF or P 30 min before breakfast and lunch for 12 weeks. The supplement was a commercially available product composed of protein, fruit, vegetable, and plant powders, as well as vitamins, minerals, pre-, and probiotics. Body weight, body composition, and blood samples were collected at days (D) 0 and 84. Statistics were conducted by ANCOVA or repeated measure ANCOVA modeling using sex and baseline values as covariates, with time and treatment as within- and between-subject variables, respectively. Per protocol analyses were included for the 133 adults who completed the study. Results Weight loss occurred throughout the study in both groups. HPF had greater weight loss at D 84 vs P (–4.0% vs −2.2% body weight, respectively; P < 0.05). Total cholesterol, LDL, and oxidized LDL decreased to a greater extent following HPF at D 84 (P < 0.05 vs D 0 and vs P), with no change in HDL cholesterol. The increase in serum adiponectin from D 0 to D 84 was greater in HPF vs P (P < 0.05) with no change in leptin. Percent body fat tended to decrease throughout the study in both groups (HPF: −1.44%, P: −1.27%; P = 0.056) with no differences between groups. There were no clinically relevant changes in assessed safety outcomes in either group. Conclusions A HPF supplement taken as a preload before breakfast and lunch improved weight loss and metabolic outcomes such as total, LDL and oxidized LDL cholesterol compared to a calorie-matched placebo. This study suggests nutrient factors other than calorie reduction alone influence the success of a weight loss regimen, potentially including nutrient density, protein and fiber content. This trial was registered at clinicaltrials.gov as NCT03057873. Funding Sources This study was funded by Beachbody, LLC.

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Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

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Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.

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