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Litramine in Weight Maintenance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01505387
First Posted: January 6, 2012
Last Update Posted: June 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
InQpharm Group
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Change in Body Weight From Baseline to End of 24 Weeks [ Time Frame: 24 weeks ]
    Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction


Secondary Outcome Measures:
  • Waist and Hip Circumference (cm) [ Time Frame: 24 weeks ]
    Changes from baseline to end of study

  • Body Mass Index (kg/m^2) [ Time Frame: 24 weeks ]
    Changes from baseline to end of study

  • Full Blood Count [ Time Frame: 24 weeks ]
    Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)

  • Blood Pressure [ Time Frame: 24 weeks ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01505387


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01505387     History of Changes
Other Study ID Numbers: INQ/024511
First Submitted: January 4, 2012
First Posted: January 6, 2012
Results First Submitted: March 24, 2015
Results First Posted: April 3, 2015
Last Update Posted: June 1, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Body Weight
Overweight
Signs and Symptoms


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