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Effect of Litramine on Fat Excretion

Sponsor
InQpharm Group (Industry)
Overall Status
Completed
CT.gov ID
NCT01590667
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Litramine
  • Device: Placebo
 Phase 4

Study Design

Study Type:
Interventional
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 1, 2012
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Difference between Litramine and placebo in changes of percentage fecal fat excretion after intervention [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 [Approximately 45 days]

    Analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes

  2. Clinical chemistry [Approximately 45 days]

    Liver function, renal function, protein metabolism, lipid metabolism

  3. Blood pressure [Approximately 45 days]

    Sitting blood pressure and heart rate will be measured using standard devices

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
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

Locations

Site City State Country Postal Code
1 Weißenseer Weg 111 Berlin Germany 10369

Sponsors and Collaborators

  • InQpharm Group

Investigators

  • Principal Investigator: Regina Busch, MD, analyze & realize AG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01590667
Other Study ID Numbers:
  • INQ/028711
First Posted:
May 3, 2012
Last Update Posted:
Jul 27, 2012
Last Verified:
Jul 1, 2012
Keywords provided by InQpharm Group
Fat excretion

Study Results

No Results Posted as of Jul 27, 2012