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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00645775
Other study ID # GHAIGOB131CT
Secondary ID
Status Completed
Phase N/A
First received March 25, 2008
Last updated March 25, 2008
Start date November 2006
Est. completion date April 2007

Study information

Verified date August 2006
Source Gateway Health Alliance
Contact n/a
Is FDA regulated No
Health authority Cameroon: Ministry of Public Health
Study type Interventional

Clinical Trial Summary

The study investigated the use and efficacy of the seeds of African bush mango (Irvingia gabonensis)to control body weight, blood lipids and hormones in overweight and obese people.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date April 2007
Est. primary completion date March 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria:

- BMI>26

Exclusion Criteria:

- Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers

Study Design

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


Intervention

Dietary Supplement:
IGOB131
Comparison of 250 mg per day of Irvingia gabonensis to placebo

Locations

Country Name City State
Cameroon Laboratory of Nutrition & Nutritional Biochemistry Yaounde Centre

Sponsors (2)

Lead Sponsor Collaborator
Gateway Health Alliance University of Yaounde

Country where clinical trial is conducted

Cameroon, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight change 10 weeks No
Secondary Change in blood lipids and hormone levels 10 weeks No
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