A Randomized Double-Blind Placebo-Controlled Clinical Study to Evaluate the Effect on the Weight of a Medical Device with Polyglucosamine L112 in a Group of Overweight and Obese Subjects.

Background: Overweight and obesity have reached epidemic proportions and safe treatments are needed to heal these diseases.

Objective: The objective of this study is to examine the activity of a medical device based on polyglucosamine polymers (PG) on body weight (BW) reduction, insulin resistance, and the serum levels of fat-soluble vitamins and glucosamine.

Methods: A double-blind placebo-controlled interventional study comparing PG and a placebo (PL) was conducted.