Polyglucosamine L112 in Overweight and Obese Subjects

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

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

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