Effect of Litramine on Fat Excretion

Study Overview
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Brief Summary
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The study aims to evaluate the effect of Litramine on fecal fat excretion in healthy subjects, to provide more comprehensive and robust clinical evidence in its mode of action for the treatment of obesity and weight management through dietary fat binding.

Official Title
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Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate the Effect of Litramine on Fecal Fat Excretion in Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Device: Litramine
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 20-30 kg/m2 Accustomed to 3 main meals/day Commitment to avoid the use of other weight management products during study Females' agreement to use appropriate birth control methods during the active study period Self-reported regular bowel movement (1-2 times per day) 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 Diabetes mellitus (type 1 or 2) History or clinical signs of endocrine disorders Clinically relevant excursions of safety parameter Current use of anti-depressants Presence of acute or chronic gastrointestinal disease Uncontrolled hypertension (more than 160/110 mm Hg) Stenosis in the gastrointestinal tract Bariatric surgery Abdominal surgery within the last 6 months prior to enrollment History of eating disorders such as bulimia, anorexia nervosa within the past 12 months Other serious organ or systemic diseases such as cancer Any medication that could influence gastrointestinal functions Pregnancy or nursing Any medication or use of products for the treatment of obesity within 6 weeks prior to enrolment History of abuse of drugs, alcohol or medication Presence of other factor(s) that, in the investigator's judgment, should preclude subject participation

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Litramine<br>2 tablets 3 times daily (oral consumption, 30 minutes after meal) | Device: Litramine<br>* 2 tablets 3 times daily (oral consumption, 30 minutes after meal)<br>|
| Placebo Comparator: Placebo<br>2 tablets 3 times daily (oral consumption, 30 minutes after meal) | 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 |
| --- | --- | --- |
| Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention | The amount of fat excreted in the feces will be quantified by the near-infrared reflectance analysis (NIRA) | 7 days per intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full blood count | Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes | Approximately 45 days | 
| Clinical chemistry | Liver function, renal function, protein metabolism, lipid metabolism | Approximately 45 days | 
| Blood pressure | Sitting blood pressure and heart rate will be measured using standard devices | Approximately 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fat excretion