Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device Based on Polyglucosamine L112® in a Group of Overweight and Obese Subjects

Azienda di Servizi alla Persona di Pavia1 site in 1 country150 target enrollmentMay 5, 2020

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Azienda di Servizi alla Persona di Pavia
Enrollment: 150
Locations: 1
Primary Endpoint: Changes on anthropometric measures
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day 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

Registry

clinicaltrials.gov

Start Date

May 5, 2020

End Date

August 19, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Azienda di Servizi alla Persona di Pavia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•weight \> 75 Kg
•absence of previous diet therapy attempts
•no fluctuation of at least 3 kg in the previous 3 months
•Beck Depression Inventory score \< 20 pt
•Binge Eating Scale score \< 27 pt

Exclusion Criteria

•allergy to shellfish
•pregnancy or breast feeding
•presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the Central Nervous System
•presence of active peptic ulcer, ulcerative colitis, Crohn's disease, celiac disease, inflammatory bowel disease
•symptomatic cholelithiasis
•previous or current neoplasms
•obesity secondary to endocrinopathies or genetic syndromes
•significant motor disability or mental retardation
•major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (I or II), schizophrenia
•previous history or current diagnosis of drug abuse or alcoholism

Outcomes

Primary Outcomes

Changes on anthropometric measures

Time Frame: Changes from baseline anthropometric measures at 90 days

Body weight (Kg)

Secondary Outcomes

Changes on Carbohydrate profile(Changes from baseline Carbohydrate profile at 90 days)
Changes on oxidative stress(Changes from baseline oxidative stress at 90 days)
Changes on safety(Changes from baseline safety at 90 days)
Changes on anthropometric measures(Changes from baseline anthropometric measures at 90 days)
Changes on lipid profile(Changes from baseline lipid profile at 90 days)
Changes on insulin resistance(Changes from baseline insulin resistance at 90 days)
Changes on body composition(Changes from baseline body composition at 90 days)