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Polyglucosamine L112 in Overweight and Obese Subjects

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Polyglucosamine L112
Placebo
Sponsored by
Azienda di Servizi alla Persona di Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Polyglucosamine, Body composition, Inflammation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Azienda di Servizi alla Persona

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control formula

Experimental formula

Arm Description

Excipients and gum arabic in tablet

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)

Outcomes

Primary Outcome Measures

Changes on anthropometric measures
Body weight (Kg)

Secondary Outcome Measures

Changes on lipid profile
Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)
Changes on insulin resistance
Homeostasis Model Assessment (pt) for evaluate insulin resistance il > 2,4
Changes on Carbohydrate profile
Glycemia (mg/dl)
Changes on Carbohydrate profile
Insulin (mcU/ml)
Changes on safety
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
Changes on safety
Gamma glutamyl transferase (U/I)
Changes on safety
Creatinine (mg/dl)
Changes on anthropometric measures
Waist circumference (cm)
Changes on anthropometric measures
Body Mass Index (Kg/m2)
Changes on body composition
Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)
Changes on oxidative stress
Reactive Oxygen Species (CARR U)
Changes on oxidative stress
Total Antioxidant Capacity (ORAC U)

Full Information

First Posted
August 20, 2021
Last Updated
August 20, 2021
Sponsor
Azienda di Servizi alla Persona di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT05022732
Brief Title
Polyglucosamine L112 in Overweight and Obese Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2020 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Polyglucosamine, Body composition, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control formula
Arm Type
Placebo Comparator
Arm Description
Excipients and gum arabic in tablet
Arm Title
Experimental formula
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyglucosamine L112
Intervention Description
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
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
excipients and gum arabic
Primary Outcome Measure Information:
Title
Changes on anthropometric measures
Description
Body weight (Kg)
Time Frame
Changes from baseline anthropometric measures at 90 days
Secondary Outcome Measure Information:
Title
Changes on lipid profile
Description
Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)
Time Frame
Changes from baseline lipid profile at 90 days
Title
Changes on insulin resistance
Description
Homeostasis Model Assessment (pt) for evaluate insulin resistance il > 2,4
Time Frame
Changes from baseline insulin resistance at 90 days
Title
Changes on Carbohydrate profile
Description
Glycemia (mg/dl)
Time Frame
Changes from baseline Carbohydrate profile at 90 days
Title
Changes on Carbohydrate profile
Description
Insulin (mcU/ml)
Time Frame
Changes from baseline Carbohydrate profile at 90 days
Title
Changes on safety
Description
Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)
Time Frame
Changes from baseline safety at 90 days
Title
Changes on safety
Description
Gamma glutamyl transferase (U/I)
Time Frame
Changes from baseline safety at 90 days
Title
Changes on safety
Description
Creatinine (mg/dl)
Time Frame
Changes from baseline safety at 90 days
Title
Changes on anthropometric measures
Description
Waist circumference (cm)
Time Frame
Changes from baseline anthropometric measures at 90 days
Title
Changes on anthropometric measures
Description
Body Mass Index (Kg/m2)
Time Frame
Changes from baseline anthropometric measures at 90 days
Title
Changes on body composition
Description
Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)
Time Frame
Changes from baseline body composition at 90 days
Title
Changes on oxidative stress
Description
Reactive Oxygen Species (CARR U)
Time Frame
Changes from baseline oxidative stress at 90 days
Title
Changes on oxidative stress
Description
Total Antioxidant Capacity (ORAC U)
Time Frame
Changes from baseline oxidative stress at 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli
Organizational Affiliation
Fondazione Casemiro Mondino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda di Servizi alla Persona
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

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Polyglucosamine L112 in Overweight and Obese Subjects

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