Dataset Information

Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study.

ABSTRACT: Litramine (IQP-G-002AS) was shown to be effective and safe for weight loss in overweight and obese subjects. However, long-term effectiveness on maintenance of body weight loss has yet to be ascertained.To assess effect of Litramine on maintenance of body weight loss.A double-blind, randomised, placebo-controlled trial on overweight and obese patients was conducted over two sites in Germany for 24 weeks. Subjects with documented previous weight loss of 3% over the last 3-6 months were randomised to groups given either Litramine (3?g/day) or a matching placebo. Primary endpoints were difference of mean body weight (kg) between baseline and end of study and maintenance of initially lost body weight in verum group, where maintenance is defined as ?1% weight gain.Subjects who were taking Litramine lost significantly more body weight compared to the subjects taking placebo who gained weight instead (-0.62 ± 1.55?kg versus 1.62 ± 1.48?kg, p < 0.001). More importantly, 92% of subjects in Litramine group were able to maintain their body weight after initial weight loss, versus 25% in placebo group. No serious adverse events were reported throughout.Litramine is effective and safe for long-term body weight maintenance. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT01505387.

SUBMITTER: Grube B

PROVIDER: S-EPMC4576018 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study.

Grube Barbara B Chong Pee-Win PW Alt Felix F Uebelhack Ralf R

Journal of obesity 20150907

<h4>Background</h4>Litramine (IQP-G-002AS) was shown to be effective and safe for weight loss in overweight and obese subjects. However, long-term effectiveness on maintenance of body weight loss has yet to be ascertained.<h4>Objective</h4>To assess effect of Litramine on maintenance of body weight loss.<h4>Methods</h4>A double-blind, randomised, placebo-controlled trial on overweight and obese patients was conducted over two sites in Germany for 24 weeks. Subjects with documented previous weigh ...[more]

PMID: 26435849

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Project description:IntroductionThe aim of this study was to evaluate the benefit and tolerability of two dosages of a proprietary flaxseed mucilage (IQP-LU-104) in reducing body weight in overweight and moderately obese individuals.MethodsIn a double-blind, randomized, placebo-controlled, bi-center trial, 108 participants (body mass index [BMI] 25-<35 kg/m2) were randomly allocated to receive either IQP-LU-104 high dose (104HD), IQP-LU-104 low dose (104LD), or placebo. Participants were instructed to consume 1 sachet of the investigational product (containing IQP-LU-104 or matching placebo) before or with main meals twice daily and to follow a balanced but hypocaloric diet (20% reduction of individual's daily energy requirements) for 12 weeks. At week 0 (baseline), and weeks 4, 8, and 12 of the intervention periods, the participants' body weight, BMI, body fat composition, and waist and hip circumferences were measured. Blood samples were collected for safety assessment at screening visit (week -2) and at the end of the study. Adverse events were assessed by the investigators through interviewing the participants and were recorded at every visit post screening.ResultsAt the end of the 12-week study, body weight reduction was greater in the 104HD group (4.96 ± 1.89 kg, p < 0.001 vs. placebo) and 104LD group (3.70 ± 2.57 kg, p < 0.001 vs. placebo) compared to the placebo group (1.33 ± 2.05 kg). 68% and 46% of participants in the 104HD group (p < 0.001 vs. placebo) and 104LD group (p = 0.002 vs. placebo), respectively, experienced at least 5% weight loss, compared to 9% of participants in the placebo group. Significant decreases in waist and hip circumferences were observed in both the 104HD and 104LD groups compared to the placebo group (each p < 0.001). 104HD group had significantly higher reduction in body fat mass (4.25 ± 5.86 kg) than the placebo group (1.06 ± 3.20 kg) (p = 0.002). Respiratory tract infections and gastrointestinal symptoms were the main adverse events reported and none of the adverse events were related to the intake of IQP-LU-104.ConclusionResults demonstrated IQP-LU-104 is safe and efficacious in body weight reduction at both dosages in overweight and moderately obese individuals.

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Project description:The effect of the novel IQP-AE-103 (proprietary combination of dehydrated okra powder and inulin) on body weight reduction and the association with changes in microbiota composition were investigated in a double-blind, randomized, placebo-controlled trial. A total of seventy-two overweight or moderately obese subjects with a body mass index of ≥25 and <35 kg/m2 were randomly allocated to receive IQP-AE-103 or placebo; each group received two IQP-AE-103 or placebo capsules three times daily, respectively. Body weight, body fat, waist circumference, and hip circumference were measured, and fecal samples were collected at baseline and after 12 weeks of intervention. Using 16S rRNA gene sequencing on the fecal samples, the microbiota dissimilarity, diversity, and differences in relative abundance between or within groups were analyzed. At the end of the study, body weight was significantly reduced in the IQP-AE-103 group compared with the placebo group, 5.16 ± 2.39 kg vs. 0.97 ± 2.09 kg (p < 0.001). Subjects from the IQP-AE-103 group who achieved a reduction of ≥5% of total body weight from baseline (hereafter referred to as 5% responders or IQP5) had a mean body weight reduction of 6.74 ± 1.94 kg, significantly greater than the placebo group (p < 0.001). Using Lefse and statistical analysis, subjects in the IQP-AE-103 group had a significantly lower relative abundance of Firmicutes than the placebo group (p < 0.05) after 12 weeks of intervention. The 5% responders from the IQP-AE-103 group had a remarkable 4.6-fold higher relative abundance of Akkermansia muciniphila than the placebo group (p < 0.05). As the significant differences between groups were only observed post-intervention, the overall differences in microbiota profile suggest that the weight loss in overweight and moderately obese subjects who consumed IQP-AE-103 for 12 weeks is accompanied by a positive change in microbiota composition. These changes might be linked to the beneficial effects of microbiome modulations in alleviating obesity and metabolic syndrome. To the best of our knowledge, we are the first to report over-the-counter (OTC) supplementation that results in both significant changes in weight and favorable shifts on the subject microbiota profile. The trial is registered under ClinicalTrials.gov Identifier no. NCT03058367.

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Dataset Information

Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study.

Publications

Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study.

Similar Datasets

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