Litramine for Weight Loss

Study Overview
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Brief Summary
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Safety and Efficacy of Litramine in weight loss.

Official Title
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Safety and Efficacy of Litramine IQP G-002AS for Weight Loss: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Litramine


Participation Criteria
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Eligibility Criteria
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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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Litramine<br>Patented fibre complex from Opuntia ficus-indica (Litramine) | Dietary Supplement: Litramine<br> <br> * Other names: IQP G-002AS;|
| Placebo Comparator: Placebo<br>Inert fillers that is manufactured to look and taste the same as verum | Dietary Supplement: Litramine<br> <br> * Other names: IQP G-002AS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight from baseline |  | 12 weeks |