Efficacy and Safety of Glucosanol™ in Body Weight Reduction

Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of Glucosanol™ in Reducing Body Weight in Overweight and Moderately Obese Subjects

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.

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