Polyglucosamine L112 in Overweight and Obese Subjects
Not Applicable
Completed
- Conditions
- Obesity
- Registration Number
- NCT05022732
- Lead Sponsor
- Azienda di Servizi alla Persona di Pavia
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes on anthropometric measures Changes from baseline anthropometric measures at 90 days Body weight (Kg)
- Secondary Outcome Measures
Name Time Method Changes on Carbohydrate profile Changes from baseline Carbohydrate profile at 90 days Insulin (mcU/ml)
Changes on oxidative stress Changes from baseline oxidative stress at 90 days Total Antioxidant Capacity (ORAC U)
Changes on safety Changes from baseline safety at 90 days Creatinine (mg/dl)
Changes on anthropometric measures Changes from baseline anthropometric measures at 90 days Body Mass Index (Kg/m2)
Changes on lipid profile Changes from baseline lipid profile at 90 days Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)
Changes on insulin resistance Changes from baseline insulin resistance at 90 days Homeostasis Model Assessment (pt) for evaluate insulin resistance il \> 2,4
Changes on body composition Changes from baseline body composition at 90 days Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)
Trial Locations
- Locations (1)
Azienda di Servizi alla Persona
🇮🇹Pavia, Italy
Azienda di Servizi alla Persona🇮🇹Pavia, Italy