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

Background Short-term treatment of overweight and obesity with plyglucosamine (PG) was found to be more effective than placebo and orlistat in double blind clinical studies, Objective To compare the efficacy of long-term (12 months) treatment for weight loss with PG and placebo (PL). Methods A double-blind randomized study in 100 subjects of both sexes, with a BMI> 30 < 35: one group of fifty cases was treated for one year with PG at 1.6 g/day and a similar group with PL. PG is a combination of low molecular weight chitosan with organic acids. Subjects were instructed to reduce their caloric intake by 10 % and increase the physical activity by 9 MET-hr/week. Dietary compliance was checked every three months using a weekly questionnaire (FIA: Food Intake Assessment) based on 25 different food servings. Body weight (BW), waist circumference (WC), blood pressure (BP), glucose, lipids, and hs-CRP were also monitored. Results Ninety-seven subjects completed the study (49 PG; 48 PL). The decrease in calories was similar in both groups as was the change in food servings (Anova p > 0.05). The BW and WC decreases were respectively 8.0 kg and 10.2 cm respectively in the PL group, whereas they were 12.1 kg and 13.3 cm in the PG group (Anova p < 0.001). The decrease in BP, plasma lipids, glucose, and hs-CRP was more evident in the group treated with PG (Anova p< 0.05). The lipids intake was found to be correlate directly with hs-CRP except for the extra virgin olive oil. In conclusion, PG was found to be more effective than PL in reducing BW, WC, glucose, BP, plasma lipids and hs-CRP in moderately obese subjects undergoing a 10 % caloric reduction and slight increase of physical activity. Dietary monitoring using FIA was an effective tool in supporting dietary compliance. The trial was also formally registered at Clinical Trial.Gov with secondary IDs number U111111292405[WHO]