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
Highlights
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
Participants treated with standard treatment (ST) + PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST + Standard treatment plus placebo-tablets (PL)
Exclusion from the clinical trial Out of the 115 patients who gave their written informed consent, a total of 28 patients were excluded from the PP population due to the following reasons: 107 patients could be evaluated, 53 patients in group ST + PL (27 patients in Center one and 26 patients in Center two, respectively) and 54 patients in group ST + PG (28 patients in Center one and 26 patients in Center two, respectively)
Summary
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. The prevalence of obesity in European countries has trebled in the last 20 years [1] together with body weight increase. Both events have a tremendous impact on quality of life and are associated with numerous comorbidities such as cardiovascular diseases, diabetes mellitus and certain cancers. The financial implication of these conditions is a cause for concern since both direct and indirect costs of illness, care and rehabilitation services will only grow larger over time. A guideline enabling practitioners and patients to make decisions about appropriate treatment and healthcare for specific clinical conditions as well as taking into account their personal circumstances, has been compiled by different professional associations in Europe as well as in Germany [3]. As a result of the increased risk of serious and sometimes fatal
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