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Effect of Litramine on Fat Excretion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590667
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : July 27, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Device: Litramine Device: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : May 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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)

Primary Outcome Measures :
  1. 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 :
  1. Full blood count [ Time Frame: Approximately 45 days ]
    Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01590667

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: InQpharm Group Identifier: NCT01590667    
Other Study ID Numbers: INQ/028711
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012
Keywords provided by InQpharm Group:
Fat excretion