Clinical trial NCT04375696: Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate Obese and Overweight Subjects
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Weight Loss
Keywords: Polyglucosamine
Formoline L112
Medical Device
Lead sponsor: Certmedica International GmbH
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Weight Loss
timeFrame: 3-month treatment
Secondary outcomes:
measure: Triglycerides
timeFrame: 3-month treatment
measure: Cholesterol
timeFrame: 3-month treatment
measure: HOMA
timeFrame: 3-month treatment
measure: Hepatic Enzymes - Renal Functionality
timeFrame: 3-month treatment
measure: BMI
timeFrame: 3-month treatment
measure: Abdominal Circumference
timeFrame: 3-month treatment
measure: DXA
timeFrame: 3-month treatment
measure: ROS
timeFrame: 3-month treatment
measure: Antioxidant Serum Capacity
timeFrame: 3-month treatment
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona Istituzioni Assistenziali Riunite di Pavia
state: Lombardia
Study officials:
affiliation: University of Pavia
name: Mariangela Rondanelli, Prof.
role: PRINCIPAL_INVESTIGATOR
References: