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

BackgroundThe 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.MethodsSixty-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.ResultsA 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 orlistatConclusionsEven 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 registrationTrial registration at ClinicalTrials.gov NCT02529631, registered on Aug 19, 2015 retrospectively registered.

Long-Term Treatment of Overweight and Obesity with Polyglucosamine (PG L112): Randomized Study Compared with Placebo in Subjects after Caloric Restriction

“…This is the first time, to our knowledge, that a long-term trial comparing PG with placebo has been conducted, and the results confirm what has been shown in previous short-term trials compared with placebo or other treatments ( 12 , 13 , 21 , 22 ). Chitosans are a family consisting of a variety of polymers, and one would expect their fat-binding capacities and glucose, biliary salts, and water affinity ( 19 – 21 , 25 ) to be different.…”

“…We can make one important observation by considering some comparable clinical trials carried out with PG. Taking the 2 previous double-blind trials with ≥3 mo of treatment at the same dosage, in one trial the average BW loss was 5.6 kg ( 12 ) (with an increase in activity of 1 MET-h/d) and in the other the average BW loss was 6.2 kg ( 13 ) (with an increase of 3 MET-h/d). In this trial, the weight loss at 3 mo was 4.7 kg (with an increase of 1.3 MET-h/d), which is significantly lower ( P < 0.05).…”

“…In short-term double-blind trials (between 12 and 24 wk) designed to compare this product with placebo ( 12 ) or orlistat ( 13 ), PG was found to be very safe and substantially more reliable than placebo or orlistat in reducing BW, BMI, and waist circumference (WC) when used in combination with caloric restriction (500 kcal/d) and increased physical activity [3–7 metabolic equivalent task hours (MET-h)/wk]. The 5% decrease in body weight was achieved in a much shorter time than with placebo.…”

Effect of Polyglucosamine on Weight Loss and Metabolic Parameters in Overweight and Obesity: A Systematic Review and Meta-Analysis

“…Polyglucosamine is a low-molecular-weight chitosan acquired through marine sources and obtained after deacetylation of chitin with deacetylation degree (DD) of >70% [9,10]. Oral polyglucosamine acts by decreasing the bioavailability of enteral dietary fats via binding to fat molecules within the lumen of the gastrointestinal tract [11,12]. Polyglucosamine is a positively charged molecule that binds with high affinity to the negatively charged enteral fat molecules, thereby forming large-sized lipid-chitosan emulsions that are weakly digested [11,12].…”

“…Oral polyglucosamine acts by decreasing the bioavailability of enteral dietary fats via binding to fat molecules within the lumen of the gastrointestinal tract [11,12]. Polyglucosamine is a positively charged molecule that binds with high affinity to the negatively charged enteral fat molecules, thereby forming large-sized lipid-chitosan emulsions that are weakly digested [11,12]. The latter process eventually restricts the absorption of dietary fats into the blood stream, hence contributing to decreased energy intake and weight loss [11,12].…”