Effect of Litramine on Fat Excretion

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: Litramine; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10369
    • Weißenseer Weg 111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Litramine; 2 tablets 3 times daily (oral consumption, 30 minutes after meal)	Device: Litramine; 2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Placebo Comparator: Placebo; 2 tablets 3 times daily (oral consumption, 30 minutes after meal)	Device: Placebo; 2 tablets 3 times daily (oral consumption, 30 minutes after meal)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Regina Busch, MD, Analyze & Realize Ag

Publications and helpful links

General Publications

• Uebelhack R, Busch R, Alt F, Beah ZM, Chong PW. Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation. Curr Ther Res Clin Exp. 2014 Jun 21;76:39-44. doi: 10.1016/j.curtheres.2014.02.001. eCollection 2014 Dec. Erratum In: Curr Ther Res Clin Exp. 2014 Sep;76:63.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (Estimate): May 3, 2012

Study Record Updates

• Last Update Posted (Estimate): July 27, 2012
• Last Update Submitted That Met QC Criteria: July 25, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Fat excretion
• Other Study ID Numbers: INQ/028711