Polyglucosamine L112 in Overweight and Obese Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Combination product: Placebo; Dietary supplement: Polyglucosamine L112

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Azienda di Servizi alla Persona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• epilepsy
• 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
• changing in smoking habits or quitting smoking in the last 6 months
• current use or in the last 3 months of psychoactive drugs or current use or in the last 12 months of drugs affecting body weight or appetite

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control formula; Excipients and gum arabic in tablet	Combination product: Placebo; excipients and gum arabic
Active Comparator: Experimental formula; Polyglucosamine L112 (750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients)	Dietary supplement: Polyglucosamine L112; 750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on anthropometric measures	Body weight (Kg)	Changes from baseline anthropometric measures at 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on lipid profile	Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)	Changes from baseline lipid profile at 90 days
Changes on insulin resistance	Homeostasis Model Assessment (pt) for evaluate insulin resistance il > 2,4	Changes from baseline insulin resistance at 90 days
Changes on Carbohydrate profile	Glycemia (mg/dl)	Changes from baseline Carbohydrate profile at 90 days
Changes on Carbohydrate profile	Insulin (mcU/ml)	Changes from baseline Carbohydrate profile at 90 days
Changes on safety	Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)	Changes from baseline safety at 90 days
Changes on safety	Gamma glutamyl transferase (U/I)	Changes from baseline safety at 90 days
Changes on safety	Creatinine (mg/dl)	Changes from baseline safety at 90 days
Changes on anthropometric measures	Waist circumference (cm)	Changes from baseline anthropometric measures at 90 days
Changes on anthropometric measures	Body Mass Index (Kg/m2)	Changes from baseline anthropometric measures at 90 days
Changes on body composition	Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)	Changes from baseline body composition at 90 days
Changes on oxidative stress	Reactive Oxygen Species (CARR U)	Changes from baseline oxidative stress at 90 days
Changes on oxidative stress	Total Antioxidant Capacity (ORAC U)	Changes from baseline oxidative stress at 90 days

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia
• Investigators: Principal Investigator: Mariangela Rondanelli, Fondazione Casemiro Mondino

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2020
• Primary Completion (Actual): August 5, 2020
• Study Completion (Actual): August 19, 2021

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Obesity; Body composition; Polyglucosamine
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: 20200037586

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No