Safety and Efficacy of Litramine in Overweight and Obese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01233349
First received: November 2, 2010
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Weight Loss
Device: Litramine
Device: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • weight loss (kg) [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

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


Enrollment: 125
Study Start Date: July 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233349

Locations
Germany
Barbara Grube
Berlin, Germany
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Barbara Grube, MD
  More Information

No publications provided by InQpharm Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01233349     History of Changes
Other Study ID Numbers: INQ/K/00310
Study First Received: November 2, 2010
Last Updated: October 12, 2011
Health Authority: State Ministry of labor protection, health protection and technical safety Berlin (Landesamt für Arbeitsschutz, Gesundheitsschutz und technische Sicherheit Berlin), Germany:

Keywords provided by InQpharm Group:
overweight
obesity
weight loss
body fat
waist circumference
satiety

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 18, 2014