Clinical trial NCT05022732: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Polyglucosamine
Body composition
Inflammation
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-08-26
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: 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


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

Primary outcomes:
measure: Changes on anthropometric measures
timeFrame: Changes from baseline anthropometric measures at 90 days
Secondary outcomes:
measure: Changes on lipid profile
timeFrame: Changes from baseline lipid profile at 90 days
measure: Changes on insulin resistance
timeFrame: Changes from baseline insulin resistance at 90 days
measure: Changes on Carbohydrate profile
timeFrame: Changes from baseline Carbohydrate profile at 90 days
measure: Changes on Carbohydrate profile
timeFrame: Changes from baseline Carbohydrate profile at 90 days
measure: Changes on safety
timeFrame: Changes from baseline safety at 90 days
measure: Changes on safety
timeFrame: Changes from baseline safety at 90 days
measure: Changes on safety
timeFrame: Changes from baseline safety at 90 days
measure: Changes on anthropometric measures
timeFrame: Changes from baseline anthropometric measures at 90 days
measure: Changes on anthropometric measures
timeFrame: Changes from baseline anthropometric measures at 90 days
measure: Changes on body composition
timeFrame: Changes from baseline body composition at 90 days
measure: Changes on oxidative stress
timeFrame: Changes from baseline oxidative stress at 90 days
measure: Changes on oxidative stress
timeFrame: Changes from baseline oxidative stress at 90 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
affiliation: Fondazione Casemiro Mondino
name: Mariangela Rondanelli
role: PRINCIPAL_INVESTIGATOR
References: