Litramine in Weight Maintenance

May 13, 2015 updated by: InQpharm Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10709
        • Barbara Grube

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist and Hip Circumference (cm)
Time Frame: 24 weeks
Changes from baseline to end of study
24 weeks
Body Mass Index (kg/m^2)
Time Frame: 24 weeks
Changes from baseline to end of study
24 weeks
Full Blood Count
Time Frame: 24 weeks
Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)
24 weeks
Blood Pressure
Time Frame: 24 weeks
Measured in mm Hg
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InQpharm Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 4, 2012

First Submitted That Met QC Criteria

January 5, 2012

First Posted (Estimate)

January 6, 2012

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INQ/024511

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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