NCT04375696

Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects

Randomized Double Blind Placebo Controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device With Polyglucosamine L 112 in a Group of Overweight and Obese Subjects: POSO Study (Polyglucosamine and Overweight)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Certmedica International GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight \> 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.

Detailed description

The primary objective of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight \> 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage. The secondary objectives of the study are: * to evaluate the effect of supplementation on blood triglyceride levels * to evaluate the effect of supplementation on blood levels of Total Cholesterol (CT), LDL, and HDL * to evaluate the effect of supplementation on glucose, insulin, insulin resistance assessed by calculating the Homeostatic metabolic assessment (HOMA) * to evaluate the effect of supplementation on liver enzymes (transaminases) and renal function (creatinine) * to evaluate the effect of supplementation on BMI (Body Mass Index) * to evaluate the effect of supplementation on the abdominal circumference * to evaluate the effect of supplementation on body composition evaluated by dual X-ray densitometer (DXA) * to evaluate the effect of supplementation on the serum levels of reactive oxygen species * to evaluate the effect of supplementation on serum antioxidant capacity

Conditions

• Weight Loss

Interventions

Type	Name	Description
DRUG	Polyglucosamine L112	Polyglucosamine; Ascorbic Acid; Tartaric Acid
OTHER	Placebo	Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide

Timeline

• Start date: 2020-04-24
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2020-05-05
• Last updated: 2022-11-22

Locations

1 site across 1 country: Italy