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Effect of Litramine on Fat Excretion

This study has been completed.
Information provided by (Responsible Party):
InQpharm Group Identifier:
First received: May 1, 2012
Last updated: July 25, 2012
Last verified: July 2012
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.

Condition Intervention Phase
Healthy Subjects Device: Litramine Device: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate the Effect of Litramine on Fecal Fat Excretion in Healthy Subjects

Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention [ Time Frame: 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:
  • Full blood count [ Time Frame: Approximately 45 days ]
    Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes

  • Clinical chemistry [ Time Frame: Approximately 45 days ]
    Liver function, renal function, protein metabolism, lipid metabolism

  • Blood pressure [ Time Frame: Approximately 45 days ]
    Sitting blood pressure and heart rate will be measured using standard devices

Enrollment: 20
Study Start Date: May 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01590667

Weißenseer Weg 111
Berlin, Germany, 10369
Sponsors and Collaborators
InQpharm Group
Principal Investigator: Regina Busch, MD analyze & realize AG
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: InQpharm Group Identifier: NCT01590667     History of Changes
Other Study ID Numbers: INQ/028711
Study First Received: May 1, 2012
Last Updated: July 25, 2012

Keywords provided by InQpharm Group:
Fat excretion processed this record on September 21, 2017