Effect of Litramine on Fat Excretion

Phase 4

Completed

• Conditions: Healthy Subjects
• Interventions: Device: Litramine; Device: Placebo

• Registration Number: NCT01590667
• Lead Sponsor: InQpharm Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-03
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Litramine	Litramine	2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Placebo	Placebo	2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Primary Outcome Measures

Name	Time	Method
Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention	7 days per intervention	The amount of fat excreted in the feces will be quantified by the near-infrared reflectance analysis (NIRA)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Weißenseer Weg 111; 🇩🇪 Berlin, Germany