Efficacy and Safety of Glucosanol™ in Body Weight Reduction
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
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Known allergy or hypersensitivity to the components of the investigational products
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Known allergy or hypersensitivity to members of the Fabaceae family
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Known food allergy (e.g. to cow's milk, eggs, wheat, crustacean, nuts etc.)
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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)
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Significant surgery within the last 6 months prior to V1:
- GI surgery
- liposuction
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History of eating disorders like bulimia, anorexia nervosa, binge-eating within the last 12 monthsprior to V1
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Clinically relevant excursions of safety laboratoryparameters
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Any electronic medical implant
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Regular use of anticoagulants
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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.)
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Consumption of food supplements or natural health products for the duration of the study
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Diet to lose and/or manage weight (except ac-cording to the study protocol)
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Vegetarian, vegan or macrobiotic diet
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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)
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Pregnancy or nursing
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History of or current abuse of drugs, alcohol or medication
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Inability to comply with study requirements
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Subjects who are deprived of their freedom by administrative or legal decision or who are in guardianship
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Participation in another clinical study in the 30 days prior to V1 and during the study
Trial design
Primary purpose
Allocation
Interventional model
Masking
90 participants in 3 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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