Efficacy and Safety of a Fungal Chitosan on the Body Weight Reduction in Overweight and Obesity Volunteers

Exclusion Criteria

• •Smoker or former smoker having stopped within 2 months prior to screening visit.
• •Subject with a history of alcohol or drug abuse.
• •Subject with physical activity more than 3 hours per week.
• •Subject with any sensitivity or allergy to any of the products used within this clinical trial.
• •Subject with history of eating disorder (anorexia nervosa, bulimia nervosa).
• •Subject having used weight reduction treatments or products during the last 3 months prior to screening visit.
• •Subject with significant gastrointestinal disease (e.g. coeliac disease, pancreatitis), signs of intestinal obstruction or medical history of constipation.
• •Intake of chronic medication which could interfere with study parameters (weight, appetite, satiety, lipid blood levels, glycemia, gastrointestinal function), having an effect on digestion or absorption of nutrients, excepted oestroprogestative or progestative contraception started at least three months before the screening visit.
• •Female subject planning a pregnancy, pregnant or breastfeeding.
• •Female subject without efficient contraceptive method.
• •Subject with history of bariatric surgery.
• •Subject with known systemic disease such as cancer, human immunodeficiency virus (HIV) seropositivity.
• •Subject with type 1 or type 2 diabetes mellitus.
• •Subject with history of significant medical or surgical event requiring hospitalization during the 3 months prior the screening visit.
• •Subject having, had or scheduling to have an exam that uses barium, a radioisotope injection, or oral or intravenous contrast material within 2 weeks prior screening visit and during the study.
• •Participation to any other clinical trial simultaneously and/or within 1 month prior the screening visit.
• •Subject who has donated blood or blood products within the previous month prior to screening or who plans to donate blood or blood products at any time during the trial and in the 3 months following the end of the study.
• •Subject judged unlikely to comply with study product intake (screening compliance \< 80%) and with diet and lifestyle instructions.