Efficacy and Safety of Glucosanol in Maintaining Body Weight

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