Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
Weight Loss
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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: ...

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

Tracking Information

NCT #
NCT04375696
Collaborators
Not Provided
Investigators
Principal Investigator: Mariangela Rondanelli, Prof. University of Pavia