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Litramine in Weight Maintenance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01505387
First received: January 4, 2012
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

The effect of Litramine on weight loss has previously been studied during a 12-week intervention period with promising results. The present study looks into the effect of weight maintenance using Litramine following initial weight loss, for a longer period of 24 weeks.


Condition Intervention Phase
Weight Maintenance
Overweight
Obese
 Dietary Supplement: Litramine
Dietary Supplement: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled Clinical Investigation to Evaluate the Safety and Efficacy of Litramine in Maintaining Body Weight Loss in Overweight and Obese Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • Mean body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Measured in kg using a calibrated scale


Secondary Outcome Measures:
  • Waist and hip circumference (cm) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from baseline to end of study

  • Body mass index (kg/m2) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes from baseline to end of study

  • Full blood count [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, MCV, MCH

  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Measured in mm Hg


Enrollment: 50
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)
 Dietary Supplement: Placebo
Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)
Experimental: Litramine
Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)
 Dietary Supplement: Litramine
Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)

  Eligibility

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

Inclusion Criteria:

  • Documented weight loss, achieved over the last 3 to 6 months either from participation in weight loss clinical trials or weight loss regimens, of at least 3% at the point of screening
  • BMI 25-35 before initial weight loss
  • Documented compliance (according to the investigator's judgement) to previous weight loss clinical trials/ regimens

Exclusion Criteria:

  • Known sensitivity to the ingredients of the device (citric acid, acacia or Fabaceae family)
  • BMI < 18.5
  • Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505387

Locations
Germany
Barbara Grube
Berlin, Germany, 10709
Sponsors and Collaborators
InQpharm Group
  More Information

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01505387     History of Changes
Other Study ID Numbers: INQ/024511
Study First Received: January 4, 2012
Last Updated: October 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by InQpharm Group:
Weight maintenance
Overweight
Obese
Weight management

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

ClinicalTrials.gov processed this record on June 18, 2013