Polyglucosamine L112 in Overweight and Obese Subjects

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Combination Product: Placebo; Dietary Supplement: Polyglucosamine L112

• Registration Number: NCT05022732
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-05
• Primary Completion: 2020-08-05
• Status Verified: 2021-08
• Study Completion: 2021-08-19
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control formula	Placebo	Excipients and gum arabic in tablet
Experimental formula	Polyglucosamine L112	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)

Primary Outcome Measures

Name	Time	Method
Changes on anthropometric measures	Changes from baseline anthropometric measures at 90 days	Body weight (Kg)

Secondary Outcome Measures

Name	Time	Method
Changes on Carbohydrate profile	Changes from baseline Carbohydrate profile at 90 days	Insulin (mcU/ml)
Changes on oxidative stress	Changes from baseline oxidative stress at 90 days	Total Antioxidant Capacity (ORAC U)
Changes on safety	Changes from baseline safety at 90 days	Creatinine (mg/dl)
Changes on anthropometric measures	Changes from baseline anthropometric measures at 90 days	Body Mass Index (Kg/m2)
Changes on lipid profile	Changes from baseline lipid profile at 90 days	Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)
Changes on insulin resistance	Changes from baseline insulin resistance at 90 days	Homeostasis Model Assessment (pt) for evaluate insulin resistance il \> 2,4
Changes on body composition	Changes from baseline body composition at 90 days	Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)

Trial Locations

Locations (1)

Azienda di Servizi alla Persona; 🇮🇹 Pavia, Italy