Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects (POSO)
Primary Purpose
Weight Loss
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Polyglucosamine L112
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Polyglucosamine, Formoline L112, Medical Device
Eligibility Criteria
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
Sites / Locations
- Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Product
Placebo
Arm Description
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg
Outcomes
Primary Outcome Measures
Weight Loss
To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
Secondary Outcome Measures
Triglycerides
To evaluate the effect of PG administration on triglycerides plasma levels
Cholesterol
To evaluate the effect of PG administration on total cholesterol plasma levels
HOMA
To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA
Hepatic Enzymes - Renal Functionality
To evaluate the effect of PG administration on transaminases and creatinine
BMI
To evaluate the effect of PG administration on BMI
Abdominal Circumference
To evaluate the effect of PG administration on the abdominal circumference
DXA
To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry)
ROS
To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels
Antioxidant Serum Capacity
To evaluate the effect of PG administration on serum antioxidant capacity
Full Information
NCT ID
NCT04375696
First Posted
April 30, 2020
Last Updated
November 17, 2022
Sponsor
Certmedica International GmbH
1. Study Identification
Unique Protocol Identification Number
NCT04375696
Brief Title
Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Certmedica International GmbH
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
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Polyglucosamine, Formoline L112, Medical Device
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Product
Arm Type
Experimental
Arm Description
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in > 75 kg
Intervention Type
Drug
Intervention Name(s)
Polyglucosamine L112
Other Intervention Name(s)
Formoline L112
Intervention Description
Polyglucosamine; Ascorbic Acid; Tartaric Acid
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide
Primary Outcome Measure Information:
Title
Weight Loss
Description
To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
Time Frame
3-month treatment
Secondary Outcome Measure Information:
Title
Triglycerides
Description
To evaluate the effect of PG administration on triglycerides plasma levels
Time Frame
3-month treatment
Title
Cholesterol
Description
To evaluate the effect of PG administration on total cholesterol plasma levels
Time Frame
3-month treatment
Title
HOMA
Description
To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA
Time Frame
3-month treatment
Title
Hepatic Enzymes - Renal Functionality
Description
To evaluate the effect of PG administration on transaminases and creatinine
Time Frame
3-month treatment
Title
BMI
Description
To evaluate the effect of PG administration on BMI
Time Frame
3-month treatment
Title
Abdominal Circumference
Description
To evaluate the effect of PG administration on the abdominal circumference
Time Frame
3-month treatment
Title
DXA
Description
To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry)
Time Frame
3-month treatment
Title
ROS
Description
To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels
Time Frame
3-month treatment
Title
Antioxidant Serum Capacity
Description
To evaluate the effect of PG administration on serum antioxidant capacity
Time Frame
3-month treatment
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli, Prof.
Organizational Affiliation
University of Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
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Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects
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