Evidence map›Paper›PMID 26217540›Full record

ArticleBMC obesity2015

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

Karina Pokhis, Norman Bitterlich, Umberto Cornelli, Giuseppina Cassano

Registry-linked trialAbstract read
In one paragraph

Article in BMC obesity, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02410785 (Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02410785 nacompletednot on this map

Efficacy of Polyglucosamine for Weight Loss - in a Randomized, Double-blind, Placebo-controlled Clinical Investigation

TypeinterventionalSponsorCertmedica International GmbHRan2009 to 2010Enrolled115ConditionsOverweight and ObesityArmsPolyglucosamine, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Karina PokhisSalztal Klinik GmbH, Parkstrasse 18, D-63628 Bad Soden-Salmünster, Germany.
Norman BitterlichMedizin & Service GmbH, Abt. Biostatistik, Boettcherstr. 10, D-09117 Chemnitz, Germany.
Umberto CornelliLoyola University, School of Medicine-Chicago, 2160 South Fist Avenue, Maywood, IL USA.
Giuseppina CassanoMAP center, Via Rossini, Rende, CS 87036 Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this clinical study was to ascertain whether low molecular weight chitosan polyglucosamine is able to produce significantly better weight loss than placebo.

method115 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.

resultsThe 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.

conclusionsParticipants treated with ST + PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST + PL.

trial registrationTrial Registration at ClinicalTrials.gov: NCT02410785 Registered 07 April 2015.

Indexed as

Body weightCaloric restrictionObesityOverweightPhysical activityPolyglucosamineWeight loss

Identifiers

PMID26217540
PMCPMC4511026

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.