Litramine in Weight Maintenance

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505387
• Other study ID #: INQ/024511
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2012
• Last updated: May 13, 2015
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: May 2015
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obese
• Overweight
• Weight Maintenance

Intervention

Dietary Supplement:
• Litramine
Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
• Placebo
Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)

Locations

Country	Name	City	State
Germany	Barbara Grube	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Body Weight From Baseline to End of 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	No
Secondary	Waist and Hip Circumference (cm)	Changes from baseline to end of study	24 weeks	No
Secondary	Body Mass Index (kg/m^2)	Changes from baseline to end of study	24 weeks	No
Secondary	Full Blood Count	Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)	24 weeks	Yes
Secondary	Blood Pressure	Measured in mm Hg	24 weeks	Yes