Effect of Litramine on Fat Excretion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01590667
First received: May 1, 2012
Last updated: July 25, 2012
Last verified: July 2012

May 1, 2012
July 25, 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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Full blood count [ Time Frame: Approximately 45 days ] [ Designated as safety issue: Yes ]
    Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes
  • Clinical chemistry [ Time Frame: Approximately 45 days ] [ Designated as safety issue: Yes ]
    Liver function, renal function, protein metabolism, lipid metabolism
  • Blood pressure [ Time Frame: Approximately 45 days ] [ Designated as safety issue: Yes ]
    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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01590667
INQ/028711
No
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