Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects
Last updated on July 2021Recruitment
- 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