efficacy and safety of glucosanol™ in body weight reduction

Conditions: Overweight and Obesity

Summary: it was proven in a previous clinical study that glucosanol™ is effective and safe in reducing weight in the overweight and obese. the present study aims at expanding the data concerning the weight management effect of glucosanol™ in overweight and moderately obese population.


Eligibility criteria:
inclusion criteria: * bmi 25 kg/m2 - 34,9 kg/m2 * generally in good health• desire to lose weight * accustomed to regular daily consumption of 3 main meals (breakfast, lunch, dinner) * consistent and stable body weight in the last 3 months prior to v1 (less than 5% self-reported change)• readiness to take ip as recommended * readiness to avoid the use of other weight loss and/or management products and/or programs during the study * readiness to adhere to diet recommendation during the study * readiness to keep the habitual level of physical activity as prior to the study during the study * readiness and ability to complete the subject diary and study questionnaires * negative pregnancy testing (beta hcg-test in urine) at v1 in women of childbearing potential * women of childbearing potential: commitment to use contraception methods exclusion criteria: * known allergy or hypersensitivity to the components of the investigational products * known allergy or hypersensitivity to members of the fabaceae family * known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.) * significant disorders: * untreated or unstable thyroid gland disorder * untreated or unstable hypertension (\>140/90 mm hg) * acute or chronic gastrointestinal (gi) disease or malabsorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) * diabetes mellitus- coagulation disorder- any other serious organ or systemic diseases that could influence the conduct and/or out-come of the study and/or could affect the tolerability of the subject (in the opinion of the investigator) * significant surgery within the last 6 months prior to v1: * gi surgery * liposuction * history of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 monthsprior to v1 * clinically relevant excursions of safety laboratoryparameters * any electronic medical implant * regular use of anticoagulants * regular medication and/or supplementation and/or treatment within the last 3 months prior to v1 and during the study: * that could influence body weight (e.g. systemic corticosteroids) * that could influence gastrointestinal functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, anti-diarrheals etc.) as per investigator judgement * for weight management (e.g. fat binder, carbohydrate/starch blocker, fat burner, satiety products, acupuncture etc.) * consumption of food supplements or natural health products for the duration of the study * diet to lose and/or manage weight (except ac-cording to the study protocol) * vegetarian, vegan or macrobiotic diet * smoking cessation within 6 months prior to v1 or during the study (regular smoking during the study at the same level as prior to the study is allowed) * pregnancy or nursing * history of or current abuse of drugs, alcohol or medication * inability to comply with study requirements * subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship * participation in another clinical study in the 30 days prior to v1 and during the study