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It was proven in a previous clinical study that Glucosanolâ„¢ 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 Glucosanolâ„¢ in overweight and moderately obese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Low dose (Glucosanol 350mg) | Experimental | Each capsule contains Glucosanol / Phaselite 350mg Subjects will take 2 capsules three times a day, 30 mins before meals. |
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| High dose (Glucosanol 500mg) | Experimental | Each capsule contains Glucosanol / Phaselite 500mg Subjects will take 2 capsules three times a day, 30 mins before meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucosanol 350mg | Dietary Supplement |
| ||
| Glucosanol 500mg |
| 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 |
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Inclusion Criteria:
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:
Significant surgery within the last 6 months prior to V1:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Uebelhack, MD | analyze & realize GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Grube | Berlin | 10709 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38830962 | Derived | Jager R, Abou Sawan S, Purpura M, Grube B, Roske Y, De Costa P, Chong PW. Proprietary alpha-amylase inhibitor formulation from white kidney bean (Phaseolus vulgaris L.) promotes weight and fat loss: a 12-week, double-blind, placebo-controlled, randomized trial. Sci Rep. 2024 Jun 3;14(1):12685. doi: 10.1038/s41598-024-63443-8. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Dietary Supplement |
|
| Placebo | Dietary Supplement |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |