A Phase 4 interventional study of Polyglucosamine L112 and Placebo in Weight Loss, sponsored by Certmedica International GmbH. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-22.
Sponsored by Certmedica International GmbH · Phase 4, Interventional, and Treatment
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.
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:
Exclusion Criteria:
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg
Drug: Polyglucosamine L112
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg
Other: Placebo
Polyglucosamine; Ascorbic Acid; Tartaric Acid
Also known as: Formoline L112
Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide
Weight Loss
To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
Time frame: 3-month treatment
Triglycerides
To evaluate the effect of PG administration on triglycerides plasma levels
Time frame: 3-month treatment
Cholesterol
To evaluate the effect of PG administration on total cholesterol plasma levels
Time frame: 3-month treatment
HOMA
To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA
Time frame: 3-month treatment
Hepatic Enzymes - Renal Functionality
To evaluate the effect of PG administration on transaminases and creatinine
Time frame: 3-month treatment
BMI
To evaluate the effect of PG administration on BMI
Time frame: 3-month treatment
Abdominal Circumference
To evaluate the effect of PG administration on the abdominal circumference
Time frame: 3-month treatment
DXA
To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry)
Time frame: 3-month treatment
ROS
To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels
Time frame: 3-month treatment
Antioxidant Serum Capacity
To evaluate the effect of PG administration on serum antioxidant capacity
Time frame: 3-month treatment
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH