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

May 1, 2012
May 3, 2012
July 27, 2012
May 2012
July 2012   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01590667 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy Subjects
  • Device: Litramine
    2 tablets 3 times daily (oral consumption, 30 minutes after meal)
  • Device: Placebo
    2 tablets 3 times daily (oral consumption, 30 minutes after meal)
  • Active Comparator: Litramine
    2 tablets 3 times daily (oral consumption, 30 minutes after meal)
    Intervention: Device: Litramine
  • Placebo Comparator: Placebo
    2 tablets 3 times daily (oral consumption, 30 minutes after meal)
    Intervention: Device: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
InQpharm Group
InQpharm Group
Not Provided
Principal Investigator: Regina Busch, MD analyze & realize AG
InQpharm Group
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP