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.
abstract: 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 testp< 0.05) respectively; BMI and WC reduction were also more consistent with polyglucosamine treatment than with orlistat treatment (t testp< 0.05). No significant difference was found in the number of subjects who achieved 5R (70% for polyglucosamine and 55% for orlistat group; chi squarep> 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.
  
  
  BACKGROUND
  Trial registration at ClinicalTrials.gov NCT02529631, registered on Aug 19, 2015 retrospectively registered.
authors.affiliation: Diabetological Center, Frankfurter Str. 50, D-63303 Dreieich, Germany.
authors.forename: Manfred
authors.initials: M
authors.lastname: Stoll
authors.affiliation: Medizin and 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, 2160 South First Avenue, Maywood, Illinois 60153 USA.
authors.forename: Umberto
authors.initials: U
authors.lastname: Cornelli
keywords: L 112; Obesity; Orlistat; Overweight; Polyglucosamine; Weight loss; Weight reduction