Polyglucosamine L112 in Overweight and Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022732
• Other study ID #: 20200037586
• Status: Completed
• Phase: N/A
• Start date: May 5, 2020
• Est. completion date: August 19, 2021

Study information

• Verified date: August 2021
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 19, 2021
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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

Combination Product:
• Placebo
excipients and gum arabic

Locations

Country	Name	City	State
Italy	Azienda di Servizi alla Persona	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

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