Weight Loss
Conditions
Brief summary
Safety and Efficacy of Litramine in weight loss.
Interventions
DIETARY_SUPPLEMENTLitramine
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects ≥18 and ≤ 60 years of age * Body mass index (BMI) ≥ 25 and ≤35 kg/m2 * Judged by the Investigator to be in general good health on the basis of medical history * Judged by the Investigator to be motivated to lose weight * Accustomed to 3 main meals per day * Consistent and stable body weight 3 months prior to study enrollment (±5%) * Consistent regular physical activity * Agree to stop all medications and supplements during the entire length of the study * Commitment to adhere to diet and lifestyle recommended for the study * Females of child bearing potential must agree to use appropriate birth control methods during the entire study period * Stable concomitant medications * Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator
Exclusion criteria
* Presence of any active gastrointestinal disease * Malabsorption disorders * Pancreatitis * Stenosis in the GI tract * Bariatric surgery/Lapband and bypass surgery * Abdominal surgery within 6 months prior to the study * Subjects whose weight increases 1.5 pounds from screening to the baseline visit * History of eating disorders like bulimia, anorexia nervosa, binge-eating * Renal conditions / disease, history of nephrolithiasis * Cardiac diseases requiring drug therapy * Other serious organ or systemic diseases such as diabetes mellitus, standard laundry list of cardiac diseases * Osteoporosis or on medications for osteoporosis * Known sensitivity to the ingredients of the study medication * Vegetarian or Vegan * Daily use of dietary supplement (2 week washout is allowed) * Any medication that could influence gastrointestinal functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped at least 3 months before study start) * Subjects who are pregnant or lactating * Any medication or use of products for the treatment of obesity (e.g., Xenical, other fat binder, fat burner, satiety products etc.) * Subjects who are currently on carbohydrate and protein diet, or low fat diet * More than 3 hours of strenuous physical activity per week * History of abuse of drugs, alcohol or medication * Smoking cessation within the 6 months prior to this study * Subjects unable to understand or follow the study protocol * Participation in similar study or weight loss program within 6 months prior to this study * Participation in other studies with in the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline | 12 weeks |
Outcome results
None listed