Safety and Efficacy of Litramine in Overweight and Obese Subjects
NCT ID: NCT01233349
Last Updated: 2011-10-13
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
PHASE3
125 participants
INTERVENTIONAL
2010-07-31
2011-01-31
Brief Summary
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Therefore, the rationale for this study is to confirm that Litramine's proven fat binding capacity to increase fat excretion and modulate the feeling of satiety will translate into measurable reduction in body weight. A double blind, randomized, placebocontrolled design has been chosen to assess the efficacy and safety of Litramine in overweight and obese subjects on a energy-restricted diet.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Litramine
Litramine
2 tablets 3 times daily (oral consumption, 30 minutes after meal)
Placebo
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
* Expressed desire for weight loss
* Accustomed to 3 main meals/day
* Consistent and stable body weight 3 months prior to study enrolment
* Commitment to avoid the use of other weight loss products during study
* Commitment to adhere to diet recommendation
* Females' agreement to use appropriate birth control methods during the active study period
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply
Exclusion Criteria
* Presence of any active gastrointestinal disease
* Malabsorption disorders (e.g. Coeliac disease)
* Pancreatitis
* Stenosis in the GI tract
* Bariatric surgery
* Abdominal surgery within the last 6 months prior to the study
* History of eating disorders like bulimia, anorexia nervosa
* History of renal disease
* History of nephrolithiasis
* History of cardiac diseases
* Osteoporosis
* Other serious organ or systemic diseases such as cancer, HIV, or diabetes mellitus
* Any medication that could influence GI functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped 3 months before study start)
* Pregnancy or nursing
* Any medication or use of products for the treatment of obesity (e.g., Orlistat, other fatbinder, fatburner, satiety products etc.)
* More than 3 hours serious sport activity per week
* History of abuse of drugs, alcohol or medication
* Smoking cessation within the 6 months prior to this study
* Inability to comply due to language difficulties
* Participation in similar studies or weight loss programs within the 6 months prior to this study
* Participation in other studies within the last 4 weeks
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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Barbara Grube, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
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Barbara Grube
Berlin, , Germany
Countries
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References
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Grube B, Chong WF, Chong PW, Riede L. Weight reduction and maintenance with IQP-PV-101: a 12-week randomized controlled study with a 24-week open label period. Obesity (Silver Spring). 2014 Mar;22(3):645-51. doi: 10.1002/oby.20577. Epub 2013 Sep 5.
Grube B, Chong PW, Lau KZ, Orzechowski HD. A natural fiber complex reduces body weight in the overweight and obese: a double-blind, randomized, placebo-controlled study. Obesity (Silver Spring). 2013 Jan;21(1):58-64. doi: 10.1002/oby.20244.
Other Identifiers
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INQ/K/00310
Identifier Type: -
Identifier Source: org_study_id