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
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ 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


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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01590667

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

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01590667     History of Changes
Other Study ID Numbers: INQ/028711
Study First Received: May 1, 2012
Last Updated: July 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by InQpharm Group:
Fat excretion

ClinicalTrials.gov processed this record on August 28, 2014