Safety and Efficacy of Litramine in Overweight and Obese Subjects

Study Overview
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Brief Summary
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Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat. Therefore, the rationale for this study is to confirm that Litramine's proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. A double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects on a energy-restricted diet.

Official Title
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Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects

Conditions
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Overweight, Obesity, Weight Loss

Intervention / Treatment
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* Device: Litramine
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

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> | Device: Litramine<br>* 2 tablets 3 times daily (oral consumption, 30 minutes after meal)<br>|
| Placebo Comparator: Placebo<br> | Device: Placebo<br>* 2 tablets 3 times daily (oral consumption, 30 minutes after meal)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss (kg) |  | after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body fat content and fat free mass |  | after 12 weeks | 
| hemogram, clinical chemistry parameter, and lipid profile |  | after 12 weeks | 
| Proportion of subjects who lost at least 5% and 10% of baseline body weight |  | after 12 weeks | 
| Subjects global feeling of satiety |  | every 4 weeks | 
| Global evaluation of the incidence of food cravings |  | every 4 weeks | 
| Changes in waist circumference (cm) |  | every 4 weeks | 
| blood pressure |  | every 4 weeks | 
| adverse events |  | every 4 weeks | 
| Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium) |  | after 8 and 12 weeks | 
| Global evaluation of safety/tolerability | by subjects and investigators - based on rating scales | after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity, weight loss, body fat, waist circumference, satiety