Effect of Litramine on Fat Excretion

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590667
• Other study ID #: INQ/028711
• Status: Completed
• Phase: Phase 4
• First received: May 1, 2012
• Last updated: July 25, 2012
• Start date: May 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Device:
• Litramine
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
• Placebo
2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Locations

Country	Name	City	State
Germany	Weißenseer Weg 111	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Full blood count	Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes	Approximately 45 days	Yes
Secondary	Clinical chemistry	Liver function, renal function, protein metabolism, lipid metabolism	Approximately 45 days	Yes
Secondary	Blood pressure	Sitting blood pressure and heart rate will be measured using standard devices	Approximately 45 days	Yes