Safety and Efficacy of Litramine in Overweight and Obese Subjects

Inclusion Criteria: * 25 ≤ BMI ≤ 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 * Presence of any active gastrointestinal disease * Malabsorption disorders (e.g. Coeliac disease) * Pancreatitis * Stenosis in the GI tract * Bariatric surgery * Abdominal surgery within the last 6 months prior to the study * History of eating disorders like bulimia, anorexia nervosa * History of renal disease * History of nephrolithiasis * History of cardiac diseases * Osteoporosis * Other serious organ or systemic diseases such as cancer, HIV, or diabetes mellitus * Any medication that could influence GI functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped 3 months before study start) * Pregnancy or nursing * Any medication or use of products for the treatment of obesity (e.g., Orlistat, other fatbinder, fatburner, satiety products etc.) * More than 3 hours serious sport activity per week * History of abuse of drugs, alcohol or medication * Smoking cessation within the 6 months prior to this study * Inability to comply due to language difficulties * Participation in similar studies or weight loss programs within the 6 months prior to this study * Participation in other studies within the last 4 weeks