Safety and Efficacy of Litramine in Overweight and Obese Subjects

Brief Summary

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”

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 Litramineʼs 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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2010

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Litramine
  • Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • weight loss (kg)
    • Time Frame: after 12 weeks
      Safety Issue?: No

Secondary Measures

  • body fat content and fat free mass
    • Time Frame: after 12 weeks
      Safety Issue?: No
  • hemogram, clinical chemistry parameter, and lipid profile
    • Time Frame: after 12 weeks
      Safety Issue?: Yes
  • Proportion of subjects who lost at least 5% and 10% of baseline body weight
    • Time Frame: after 12 weeks
      Safety Issue?: No
  • Subjects global feeling of satiety
    • Time Frame: every 4 weeks
      Safety Issue?: No
  • Global evaluation of the incidence of food cravings
    • Time Frame: every 4 weeks
      Safety Issue?: No
  • Changes in waist circumference (cm)
    • Time Frame: every 4 weeks
      Safety Issue?: No
  • blood pressure
    • Time Frame: every 4 weeks
      Safety Issue?: Yes
  • adverse events
    • Time Frame: every 4 weeks
      Safety Issue?: Yes
  • Fat-soluble vitamins (A, D, E) and electrolytes (calcium, magnesium, sodium, potassium)
    • Time Frame: after 8 and 12 weeks
      Safety Issue?: Yes
  • Global evaluation of safety/tolerability
    • Time Frame: after 12 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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
  • Femalesʼ 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • InQpharm Group
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Barbara Grube, MD, Principal Investigator,

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01233349