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

Abstract

Background: Short-term treatment of overweight and obesity with polyglucosamine (PG) was found to be more effective than placebo and orlistat in double-blind clinical studies. Objective: The aim of the study was to compare the efficacy of long-term (12-mo) treatment of weight loss with PG and placebo (PL). Methods: This was a double-blind randomized study in 100 participants of both sexes with a body mass index (in kg/m2) >30 to <35. One group of 50 participants was treated for 1 y with PG at 1.6 g/d and a similar group received PL. PG is a combination of low-molecular-weight chitosan with organic acids. Participants were instructed to reduce their caloric intake by 10% and increase the physical activity level by 9 metabolic equivalent task hours/wk. Dietary compliance was checked every 3 mo by using a weekly questionnaire [food intake assessment (FIA)] based on 25 different food servings. Body weight (BW), waist circumference (WC), blood pressure (BP), glucose, lipids, and high-sensitivity C-reactive protein (hs-CRP) were also monitored. Results: Ninety-seven participants completed the study (49 in the PG group, 48 in the PL group). The decrease in calories was similar in both groups, as was the change in number of food servings (P > 0.05, ANOVA). Decreases in BW and WC were 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 (P < 0.001, ANOVA). The decrease in BP, plasma lipids, glucose, and hs-CRP was more evident in the group treated with PG (P < 0.05, ANOVA). The intake of lipids was found to correlate directly with hs-CRP, with the exception of extra-virgin olive oil. Conclusions: PG was found to be more effective than PL in reducing BW, WC, glucose, BP, plasma lipids, and hs-CRP in moderately obese individuals undergoing a 10% caloric reduction and a slight increase in physical activity. Dietary monitoring with the use of an FIA was an effective tool in supporting dietary compliance. This trial was registered at clinicaltrials.gov as U111111292405 (WHO).

Obstructive sleep apnea: standard management and the use of an artificial saliva in a registry study

“…The data of the present study are a confirmation of what has been described in children suffering from Down syndrome and OSA [10], who were having clinical benefit increasing the oral wettability and hygiene.…”

“…Patients had to be familiar with the Food Intake Questionnaire [10] because they were part of the screening program for the asymptomatic vascular disease [14] using FIA (for food intake control) and following a SM. in only, whereas at baseline and after 4 weeks of treatment values were taken only in the last day of the week.…”

“…In this way the limitation of food intake (-10 % of daily calorie intake) together with the increase of physical activity (9 MET-h/week) seems to be affordable at long term since in one year it was possible to obtain an average BW reduction of about 0.6 Kg/month (8 kg/year) [10].…”

“…The FIA consisted of 25 different type of servings composed by the most common 250 Italian foods [10]. Some suggestion was given to participants to prepare servings with reducing pasta and increasing vegetables or pulses, to use more eggs to reduce cheese and processed meat.…”

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

“…Several clinical trials have investigated the effects of polyglucosamines on weight loss in subjects with overweight and obesity [9,11,12,[14][15][16]. A few of these studies demonstrated significant reductions in body weight, whereas others were inconclusive.…”