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Completed

NCT Number: NCT04375696

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

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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia

Pavia, Lombardy, 27100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyglucosamine L112

Drug

Polyglucosamine; Ascorbic Acid; Tartaric Acid

Other names: Formoline L112

Placebo

Other

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

Primary outcomes

  1. Weight Loss

    Time frame: 3-month treatment

    To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)

Secondary outcomes

  1. Triglycerides

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on triglycerides plasma levels

  2. Cholesterol

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on total cholesterol plasma levels

  3. HOMA

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA

  4. Hepatic Enzymes - Renal Functionality

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on transaminases and creatinine

  5. BMI

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on BMI

  6. Abdominal Circumference

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on the abdominal circumference

  7. DXA

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry)

  8. ROS

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels

  9. Antioxidant Serum Capacity

    Time frame: 3-month treatment

    To evaluate the effect of PG administration on serum antioxidant capacity

Sponsors and collaborators

Lead sponsor

Certmedica International GmbH

Industry

Registry information

Official study 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)

Acronym: POSO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 5, 2020
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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