Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects

Study Overview
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Brief Summary
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Glucosanol™, the medical device to be investigated contains a proprietary plant extract that is a natural inhibitor of alpha-amylase and can reduce starch digestion. The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese.

Detailed Description
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Preparations that reduce absorption of calories from dietary carbohydrates could be decisively meaningful for the regulation of bodyweight or obesity. Hence, Glucosanol™ may be used as a tool for the treatment of obesity and weight management through reduced carbohydrate absorption. The rationale for this study is to confirm that Glucosanol™ ingestion will reduce body weight. A double-blind, randomized, placebo-controlled design has been chosen to assess the efficacy and safety of Glucosanol™ in subjects who are overweight and mildly obese. The specific hypotheses to be accepted or rejected by statistical data from the clinical investigation are beneficial effects of the device on weight loss (kg) and body fat content.

Official Title
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Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of Glucosanol in Reducing Body Weight in Overweight and Obese Subjects

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Device: Glucosanol
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 60 years BMI between 25 and 35 Expressed desire for weight loss Accustomed to 3 main meals/day Consistent and stable body weight 3 months prior to study enrolment Commitment to avoid the use of other weight loss products during study Commitment to adhere to diet recommendation Females' agreement to use appropriate birth control methods during the active study period Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply Exclusion Criteria: Known sensitivity to the ingredients of the device History of Diabetes mellitus Fasting blood glucose >7 mmol/L History or clinical signs of endocrine disorders which may influence body weight (e.g., Cushing's disease, thyroid gland disorders) Clinically relevant excursions of safety parameter Current use of anti-depressants Presence of acute or chronic gastrointestinal disease (e.g., IBD, coeliac disease. pancreatitis) Uncontrolled hypertension (>160/110 mm Hg) Stenosis in the GI tract Bariatric surgery Abdominal surgery within the last 6 months prior to enrollment History of eating disorders such as bulimia, anorexia nervosa within the past 12 months Other serious organ or systemic diseases such as cancer Any medication that could influence GI functions such as antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or antidiarrheals (e.g., loperamide; must have stopped 1 months before study start) Pregnancy or nursing Any medication or use of products for the treatment of obesity More than 3 hours strenuous sport activity per week History of abuse of drugs, alcohol or medication Smoking cessation within 6 months prior to enrolment Inability to comply due to language difficulties Participation in similar studies or weight loss programs within 3 months prior to enrolment Participation in other studies within 4 weeks prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucosanol<br>Glucosanol | Device: Glucosanol<br>* 2 tablets 3x daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Device: Placebo<br>* 2 tablets 3x daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | The primary endpoint of this randomized, double-blind, placebo-controlled bicen-tric study is to assess the weight loss effect of Glucosanol™ (kg), in combination with a weight loss program in overweight and obese subjects. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion body weight | To assess the efficacy of Glucosanol™ to increase the proportions of subjects who lose at least 3% and 5% of baseline body weight | 12 weeks | 
| waist circumference | Changes in waist circumference | 12 weeks | 
| hip circumference | Changes in hip circumference | 12 weeks | 
| waist-hip-ratio | Changes in waist-hip-ratio | 12 weeks | 
| BMI | Changes in BMI | 12 weeks | 
| body fat | Changes in body fat (% and kg) and fat free mass (kg) | 12 weeks | 
| hunger | Changes in hunger, eating, and food craving-related items from a Control of Eating Questionnaire | 12 weeks | 
| Global evaluation of feeling of satiety | This parameter will be assessed by a 4 points categorical scale | 12 weeks | 
| Global evaluation of the efficacy | This parameter will be assessed by a 4 points categorical scale | 12 weeks | 
| Global evaluation of safety | This will be assessed by both investigators and subjects by a 4 points categorical scale. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, weight loss, body fat, waste cirumference, satiety, appetite