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
  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:


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
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: 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 July 31, 2014