Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2012-05-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Litramine
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Litramine
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Placebo
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Placebo
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Interventions
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Litramine
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Placebo
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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InQpharm Group
INDUSTRY
Responsible Party
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Principal Investigators
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Regina Busch, MD
Role: PRINCIPAL_INVESTIGATOR
analyze & realize AG
Locations
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Weißenseer Weg 111
Berlin, State of Berlin, Germany
Countries
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References
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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.
Other Identifiers
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INQ/028711
Identifier Type: -
Identifier Source: org_study_id