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

Background. 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. Objective. To assess effect of Litramine on maintenance of body weight loss. Methods...

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Main Authors: Barbara Grube, Pee-Win Chong, Felix Alt, Ralf Uebelhack
Format: Article
Language:English
Published: Hindawi Limited 2015-01-01
Series:Journal of Obesity
Online Access:http://dx.doi.org/10.1155/2015/953138
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spelling doaj-b3c64db189954e9b9071624a348bbf782020-11-24T23:12:23ZengHindawi LimitedJournal of Obesity2090-07082090-07162015-01-01201510.1155/2015/953138953138Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled StudyBarbara Grube0Pee-Win Chong1Felix Alt2Ralf Uebelhack3Practice for General Medicine, Kurfürstendamm 157/158, 10709 Berlin, GermanyZaluvida Corporate Sdn Bhd, E-16 Plaza Mont Kiara, 2 Jalan Kiara, 50480 Kuala Lumpur, MalaysiaAnalyze & Realize GmbH, Waldseeweg 6, 13467 Berlin, GermanyAnalyze & Realize GmbH, Weißenseer Weg 111, 10369 Berlin, GermanyBackground. 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. Objective. To assess effect of Litramine on maintenance of body weight loss. Methods. 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. Results. 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. Conclusion. Litramine is effective and safe for long-term body weight maintenance. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT01505387.http://dx.doi.org/10.1155/2015/953138
collection DOAJ
language English
format Article
sources DOAJ
author Barbara Grube
Pee-Win Chong
Felix Alt
Ralf Uebelhack
spellingShingle Barbara Grube
Pee-Win Chong
Felix Alt
Ralf Uebelhack
Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study
Journal of Obesity
author_facet Barbara Grube
Pee-Win Chong
Felix Alt
Ralf Uebelhack
author_sort Barbara Grube
title Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study
title_short Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study
title_full Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study
title_fullStr Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study
title_full_unstemmed Weight Maintenance with Litramine (IQP-G-002AS): A 24-Week Double-Blind, Randomized, Placebo-Controlled Study
title_sort weight maintenance with litramine (iqp-g-002as): a 24-week double-blind, randomized, placebo-controlled study
publisher Hindawi Limited
series Journal of Obesity
issn 2090-0708
2090-0716
publishDate 2015-01-01
description Background. 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. Objective. To assess effect of Litramine on maintenance of body weight loss. Methods. 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. Results. 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. Conclusion. Litramine is effective and safe for long-term body weight maintenance. Trial Registration. This trial is registered with Clinicaltrials.gov identifier: NCT01505387.
url http://dx.doi.org/10.1155/2015/953138
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