Overweight and Obesity
Conditions
Brief 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.
Interventions
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in mean body weight (kg) after 12 weeks of IP intake in comparison between the verum 500mg study arm and placebo | 12 weeks |
Countries
Germany
Outcome results
None listed