Litramine in Weight Maintenance

Phase 4

Completed

• Conditions: Overweight; Weight Maintenance; Obese
• Interventions: Dietary Supplement: Litramine; Dietary Supplement: Placebo

• Registration Number: NCT01505387
• Lead Sponsor: InQpharm Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2015-03-24
• Results First Submitted QC: 2015-03-24
• Results First Posted: 2015-04-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-13
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Litramine	Litramine	Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)
Placebo	Placebo	Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)

Primary Outcome Measures

Name	Time	Method
Mean Change in Body Weight From Baseline to End of 24 Weeks	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

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

Trial Locations

Locations (1)

Barbara Grube; 🇩🇪 Berlin, Germany