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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Barbara Grube | Berlin |
Lead Sponsor | Collaborator |
---|---|
InQpharm Group |
Germany,
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 |
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