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

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)

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Drug: Polyglucosamine L112; Other: Placebo

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Pavia, Lombardia, Italy, 27100
      • Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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
Experimental: Product; 75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg	Drug: Polyglucosamine L112; Polyglucosamine; Ascorbic Acid; Tartaric Acid; Other Names: Formoline L112
Placebo Comparator: Placebo; 75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg	Other: Placebo; Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)	3-month treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides	To evaluate the effect of PG administration on triglycerides plasma levels	3-month treatment
Cholesterol	To evaluate the effect of PG administration on total cholesterol plasma levels	3-month treatment
HOMA	To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA	3-month treatment
Hepatic Enzymes - Renal Functionality	To evaluate the effect of PG administration on transaminases and creatinine	3-month treatment
BMI	To evaluate the effect of PG administration on BMI	3-month treatment
Abdominal Circumference	To evaluate the effect of PG administration on the abdominal circumference	3-month treatment
DXA	To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry)	3-month treatment
ROS	To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels	3-month treatment
Antioxidant Serum Capacity	To evaluate the effect of PG administration on serum antioxidant capacity	3-month treatment

Collaborators and Investigators

• Sponsor: Certmedica International GmbH
• Investigators: Principal Investigator: Mariangela Rondanelli, Prof., University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Medical Device; Polyglucosamine; Formoline L112
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: IT-1501202

Drug and device information, study documents

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