title: Efficacy of polyglucosamine for weight loss-confirmed in a randomized double-blind, placebo-controlled clinical investigation.
abstract: BACKGROUND
  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.
  
  
  METHODS
  115 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  Participants treated with ST + PG showed a significant amount of weight loss, an additional 1.8 kg, compared to controls treated with ST + PL.
  
  
  BACKGROUND
  Trial Registration at ClinicalTrials.gov: NCT02410785 Registered 07 April 2015.
authors.affiliation: Salztal Klinik GmbH, Parkstrasse 18, D-63628 Bad Soden-Salmünster, Germany.
authors.forename: Karina
authors.initials: K
authors.lastname: Pokhis
authors.affiliation: Medizin & Service GmbH, Abt. Biostatistik, Boettcherstr. 10, D-09117 Chemnitz, Germany.
authors.forename: Norman
authors.initials: N
authors.lastname: Bitterlich
authors.affiliation: Loyola University, School of Medicine-Chicago, 2160 South Fist Avenue, Maywood, IL USA.
authors.forename: Umberto
authors.initials: U
authors.lastname: Cornelli
authors.affiliation: MAP center, Via Rossini, Rende, CS 87036 Italy.
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Cassano
keywords: Body weight; Caloric restriction; Obesity; Overweight; Physical activity; Polyglucosamine; Weight loss