Cargando…

Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity

BACKGROUND: The efficacy of a non-prescription drug to support weight loss programs has yet to be compared. This clinical trial investigates the comparability of orlistat 60 milligram (mg) and polyglucosamine. METHODS: Sixty-four overweight or obese subjects were included in a two-center double-blin...

Descripción completa

Detalles Bibliográficos
Autores principales: Stoll, Manfred, Bitterlich, Norman, Cornelli, Umberto
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5225614/
https://www.ncbi.nlm.nih.gov/pubmed/28097013
http://dx.doi.org/10.1186/s40608-016-0130-4
_version_ 1782493544948170752
author Stoll, Manfred
Bitterlich, Norman
Cornelli, Umberto
author_facet Stoll, Manfred
Bitterlich, Norman
Cornelli, Umberto
author_sort Stoll, Manfred
collection PubMed
description BACKGROUND: The efficacy of a non-prescription drug to support weight loss programs has yet to be compared. This clinical trial investigates the comparability of orlistat 60 milligram (mg) and polyglucosamine. METHODS: Sixty-four overweight or obese subjects were included in a two-center double-blind study. One center was in Germany [center 1] and the other was in Italy [center 2]. The subjects (26 in center 1 and 38 in center 2) were recommended to follow a calorie deficit of about 2000 kilojoules/day and to increase their physical activity to 3 metabolic equivalent hours (MET h)/day. In both centers, subjects were randomized to receive polyglucosamine (2 tablets x 2) or orlistat (1 capsule x 3) for a period of 12 weeks. Weight loss was considered as a main variable together with the reduction of 5 per cent (%) of body weight (5R). Body Mass Index (BMI) and waist circumference (WC) were taken as secondary variables. RESULTS: A significant difference in weight loss between the two groups was shown, 6.7 ± 3.14 kilogram (kg) in group polyglucosamine versus 4.8 ± 2.24 kg in group orlistat (t test p < 0.05) respectively; BMI and WC reduction were also more consistent with polyglucosamine treatment than with orlistat treatment (t test p < 0.05). No significant difference was found in the number of subjects who achieved 5R (70% for polyglucosamine and 55% for orlistat group; chi square p > 0.05). The administration of polyglucosamine following energy restriction and increase in physical activity reduces body weight, BMI and WC more efficiently than orlistat CONCLUSIONS: Even though both groups were instructed to adopt a calorie restricted diet together with increased physical activity an additional weight loss in the polyglucosamine group of 1.6 kilogram (kg) compared to the orlistat group (6.2 ± 3.46 versus 4.6 ± 2.36 kg) in both centers was seen despite the higher consumption of carbohydrates in Italy (center 2). A typical Italian diet is usually high in carbohydrate content whereas Germans tend to consume meals with higher fat content. This leads to the assumption that polyglucosamine limits both fat and carbohydrate absorption which would explain the comparable effective weight reduction in the Italian participants. TRIAL REGISTRATION: Trial registration at ClinicalTrials.gov NCT02529631, registered on Aug 19, 2015 retrospectively registered.
format Online
Article
Text
id pubmed-5225614
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-52256142017-01-17 Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity Stoll, Manfred Bitterlich, Norman Cornelli, Umberto BMC Obes Research Article BACKGROUND: The efficacy of a non-prescription drug to support weight loss programs has yet to be compared. This clinical trial investigates the comparability of orlistat 60 milligram (mg) and polyglucosamine. METHODS: Sixty-four overweight or obese subjects were included in a two-center double-blind study. One center was in Germany [center 1] and the other was in Italy [center 2]. The subjects (26 in center 1 and 38 in center 2) were recommended to follow a calorie deficit of about 2000 kilojoules/day and to increase their physical activity to 3 metabolic equivalent hours (MET h)/day. In both centers, subjects were randomized to receive polyglucosamine (2 tablets x 2) or orlistat (1 capsule x 3) for a period of 12 weeks. Weight loss was considered as a main variable together with the reduction of 5 per cent (%) of body weight (5R). Body Mass Index (BMI) and waist circumference (WC) were taken as secondary variables. RESULTS: A significant difference in weight loss between the two groups was shown, 6.7 ± 3.14 kilogram (kg) in group polyglucosamine versus 4.8 ± 2.24 kg in group orlistat (t test p < 0.05) respectively; BMI and WC reduction were also more consistent with polyglucosamine treatment than with orlistat treatment (t test p < 0.05). No significant difference was found in the number of subjects who achieved 5R (70% for polyglucosamine and 55% for orlistat group; chi square p > 0.05). The administration of polyglucosamine following energy restriction and increase in physical activity reduces body weight, BMI and WC more efficiently than orlistat CONCLUSIONS: Even though both groups were instructed to adopt a calorie restricted diet together with increased physical activity an additional weight loss in the polyglucosamine group of 1.6 kilogram (kg) compared to the orlistat group (6.2 ± 3.46 versus 4.6 ± 2.36 kg) in both centers was seen despite the higher consumption of carbohydrates in Italy (center 2). A typical Italian diet is usually high in carbohydrate content whereas Germans tend to consume meals with higher fat content. This leads to the assumption that polyglucosamine limits both fat and carbohydrate absorption which would explain the comparable effective weight reduction in the Italian participants. TRIAL REGISTRATION: Trial registration at ClinicalTrials.gov NCT02529631, registered on Aug 19, 2015 retrospectively registered. BioMed Central 2017-01-11 /pmc/articles/PMC5225614/ /pubmed/28097013 http://dx.doi.org/10.1186/s40608-016-0130-4 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Stoll, Manfred
Bitterlich, Norman
Cornelli, Umberto
Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity
title Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity
title_full Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity
title_fullStr Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity
title_full_unstemmed Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity
title_short Randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity
title_sort randomised, double-blind, clinical investigation to compare orlistat 60 milligram and a customized polyglucosamine, two treatment methods for the management of overweight and obesity
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5225614/
https://www.ncbi.nlm.nih.gov/pubmed/28097013
http://dx.doi.org/10.1186/s40608-016-0130-4
work_keys_str_mv AT stollmanfred randomiseddoubleblindclinicalinvestigationtocompareorlistat60milligramandacustomizedpolyglucosaminetwotreatmentmethodsforthemanagementofoverweightandobesity
AT bitterlichnorman randomiseddoubleblindclinicalinvestigationtocompareorlistat60milligramandacustomizedpolyglucosaminetwotreatmentmethodsforthemanagementofoverweightandobesity
AT cornelliumberto randomiseddoubleblindclinicalinvestigationtocompareorlistat60milligramandacustomizedpolyglucosaminetwotreatmentmethodsforthemanagementofoverweightandobesity