Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects

Weight Loss Clinical Trial

— POSO  

Official title:

Randomized Double Blind Placebo Controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device With Polyglucosamine L 112 in a Group of Overweight and Obese Subjects: POSO Study (Polyglucosamine and Overweight)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04375696
• Other study ID #: IT-1501202
• Status: Completed
• Phase: Phase 4
• Start date: April 24, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: November 2022
• Source: Certmedica International GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose 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.

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:

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent

• Age between 18-65

• Both sexes - mandatory adequate contraceptive method for women in fertility age

• BMI between 25-32 kg/m2 and weigh in > 75 kg, with no previous diet-therapy attempts with at least a 5% weight loss in the last year

• No 3 kg weight fluctuation in the last 3 months

• Beck Depression Inventory (BDI) score < 20

• Binge Eating Scale (BES) score < 27

Exclusion Criteria:

• Shellfish allergy or to any other ingredient in the product

• Previous diet-therapy attempts with at least a 5% weight loss in the last year

• 3 kg weight fluctuation in the last 3 months

• Presumed or confirmed pregnancy

• No contraceptive method for women in fertility age

• Cardiopathies, nephropathies, hepatopathies, bronchopneumopathies, hemopathies dermopathies clinically significant chronic degenerative CNS (Central Nervous System) diseases

• Active peptic ulcer, ulcerative colitis, Crohn disease, celiac disease, inflammatory bowel disease

• Alcoholism

• Epilepsy

• Past or current malignancies

• Intellectual disability

• Significant motor disability

• Drug abuse

• Autoimmune diseases

• Symptomatic cholelithiasis

Related Conditions & MeSH terms

• Overweight
• Weight Loss

Intervention

Drug:
• Polyglucosamine L112
Polyglucosamine; Ascorbic Acid; Tartaric Acid

Other:
• Placebo
Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide

Locations

Country	Name	City	State
Italy	Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia	Pavia	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Certmedica International GmbH

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)	3-month treatment
Secondary	Triglycerides	To evaluate the effect of PG administration on triglycerides plasma levels	3-month treatment
Secondary	Cholesterol	To evaluate the effect of PG administration on total cholesterol plasma levels	3-month treatment
Secondary	HOMA	To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA	3-month treatment
Secondary	Hepatic Enzymes - Renal Functionality	To evaluate the effect of PG administration on transaminases and creatinine	3-month treatment
Secondary	BMI	To evaluate the effect of PG administration on BMI	3-month treatment
Secondary	Abdominal Circumference	To evaluate the effect of PG administration on the abdominal circumference	3-month treatment
Secondary	DXA	To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry)	3-month treatment
Secondary	ROS	To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels	3-month treatment
Secondary	Antioxidant Serum Capacity	To evaluate the effect of PG administration on serum antioxidant capacity	3-month treatment