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Safety and Efficacy of Litramine in Overweight and Obese Subjects

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ClinicalTrials.gov Identifier: NCT01233349
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : October 13, 2011
Information provided by (Responsible Party):
InQpharm Group

Brief Summary:

Preparations that bind to nutritional fat and inhibit its absorption could be decisively meaningful for the regulation of bodyweight or obesity. Further, it is known that soluble fibres gel and swell in the stomach and thereby induce a feeling of satiety or fullness after eating. Such effects are supposed to facilitate adherence to energy-restricted diets. The medical device to be investigated contains a patented formula of fibre complex having a high ability to bind to dietary fat.

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Weight Loss Device: Litramine Device: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate Safety and Efficacy of LitramineTM in Reducing Body Weight in Overweight and Obese Subjects
Study Start Date : July 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Litramine Device: Litramine
2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Placebo Comparator: Placebo Device: Placebo
2 tablets 3 times daily (oral consumption, 30 minutes after meal)

Primary Outcome Measures :
  1. weight loss (kg) [ Time Frame: after 12 weeks ]

Secondary Outcome Measures :
  1. body fat content and fat free mass [ Time Frame: after 12 weeks ]
  2. hemogram, clinical chemistry parameter, and lipid profile [ Time Frame: after 12 weeks ]
  3. Proportion of subjects who lost at least 5% and 10% of baseline body weight [ Time Frame: after 12 weeks ]
  4. Subjects global feeling of satiety [ Time Frame: every 4 weeks ]
  5. Global evaluation of the incidence of food cravings [ Time Frame: every 4 weeks ]
  6. Changes in waist circumference (cm) [ Time Frame: every 4 weeks ]
  7. blood pressure [ Time Frame: every 4 weeks ]
  8. adverse events [ Time Frame: every 4 weeks ]
  9. Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium) [ Time Frame: after 8 and 12 weeks ]
  10. Global evaluation of safety/tolerability [ Time Frame: after 12 weeks ]
    by subjects and investigators - based on rating scales

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 25 ≤ BMI ≤ 35
  • 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:

  • Known sensitivity to the ingredients of the device
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233349

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Barbara Grube
Berlin, Germany
Sponsors and Collaborators
InQpharm Group
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Principal Investigator: Barbara Grube, MD
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01233349    
Other Study ID Numbers: INQ/K/00310
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011
Keywords provided by InQpharm Group:
weight loss
body fat
waist circumference
Additional relevant MeSH terms:
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Weight Loss
Body Weight
Body Weight Changes