- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00645775
Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome
The Efficacy of Irvingia Gabonensis (Bush Mango) in the Management of Overweight, Obesity and Metabolic Syndrome in Cameroon.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To assess the effects of seeds of Irvingia gabonensis on body weight, fasting blood glucose, plasma total and LDL cholesterol in 102 overweight and obese participants.
The study was a 10 week randomized, double blind, placebo controlled design. participants were randomly divided into 2 groups of 51 participants each. Group 1 was the placebo group, while Group 2 was the active group. Each group received 2 daily doses of 125 mg (before meals) of either placebo or Irvingia gabonensis.
Weight as well as fasting blood was taken at baseline and at 4, 8 and 10 weeks. No major detary changes or exercises were suggested during the study period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Centre
-
Yaounde, Centre, Cameroon, BP812
- Laboratory of Nutrition & Nutritional Biochemistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI>26
Exclusion Criteria:
- Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers
Study Plan
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: 1
Compare active to placebo
|
Comparison of 250 mg per day of Irvingia gabonensis to placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight change
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in blood lipids and hormone levels
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Julius E Oben, PhD, Gateway Health Alliances / University of Yaounde
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHAIGOB131CT
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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