Efficacy and Safety of Glucosanol in Maintaining Body Weight

Study Overview
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Brief Summary
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To date, there is no clinical evidence on the efficacy and safety of Glucosanol in maintaining weight loss beyond the study duration of 12 weeks. The rationale for this open-label study is to assess the efficacy in preventing regain of loss body weight and safety of Glucosanol in subjects who are overweight or obese over a longer period after the initial weight loss.

Official Title
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Open-label Clinical Investigation to Evaluate the Safety and Efficacy of Glucosanol in Maintaining Body Weight Loss in Overweight and Obese Subjects

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Device: Glucosanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously enrolled in, complied with, and completed the INQ/K/003411 (Glucosanol weight loss) study, with weight loss of at least 3% of baseline body weight Age 18 to 60 years at the time of inclusion into the INQ/K/003411 study BMI between 25-35 at the time of inclusion into the INQ/K/003411 study Expressed desire for weight maintenance Accustomed to 3 main meals per day Commitment to avoid the use of other weight loss products during study 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 (Phaseolus vulgaris or members of the Fabaceae family) History of diabetes mellitus • Fasting blood glucose more than 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 (more than 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 like 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 anti-diarrheals Pregnancy or nursing Any medication or use of products for the treatment of obesity (e.g. Orlistat, other fatbinder, carb/starch blocker, fatburner, satiety products etc.) 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 Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucosanol<br>2 tablets 3 times a day | Device: Glucosanol<br>* 2 tablets taken 3 times a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Measured in kg using a calibrated scale | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist and hip circumference (cm) | Changes from baseline to end of study | 24 weeks | 
| Body mass index, BMI (kg/m2) | Changes from baseline to end of study | 24 weeks | 
| Body fat content and fat free mass | Changes from baseline to end of study | 24 weeks | 
| Effect on appetite, hunger and food cravings | The Control of Eating Questionnaire (COEQ) is used | 24 weeks | 
| Feeling of satiety | A 4-point categorical scale is used | 24 weeks | 
| Evaluation of the efficacy of Glucosanol by the subjects | A 4-point categorical scale is used | 24 weeks | 
| Full blood count | Done at baseline and end of study | 24 weeks | 
| Clinical chemistry parameter | Done at baseline and end of study | 24 weeks | 
| Blood pressure | Measured in mm Hg | 24 weeks | 
| Global evaluation of the safety of Glucosanol by the subjects | A 4-point categorical scale is used. | 24 weeks | 
| Global evaluation of the safety of Glucosanol by the investigators | A 4-point categorical scale is used | 24 weeks | 
| Occurrence of adverse events | All reported adverse events, regardless of causality, will be recorded in the source documents and case report forms | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight maintenance, BMI, Body weight, Overweight, Obesity, Satiety