Efficacy and Safety of Glucosanol™ in Body Weight Reduction

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Glucosanol 350mg
* Dietary Supplement: Glucosanol 500mg
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The placebo is identical in shape, colour and size to the active comparator with the active ingredient replaced with microcrystalline cellulose. Subjects will take 2 capsules three times a day, 30 mins before meals. | Dietary Supplement: Placebo<br> <br> |
| Experimental: Low dose (Glucosanol 350mg)<br>Each capsule contains Glucosanol / Phaselite 350mg Subjects will take 2 capsules three times a day, 30 mins before meals. | Dietary Supplement: Glucosanol 350mg<br> <br> |
| Experimental: High dose (Glucosanol 500mg)<br>Each capsule contains Glucosanol / Phaselite 500mg Subjects will take 2 capsules three times a day, 30 mins before meals. | Dietary Supplement: Glucosanol 500mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |