Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Obesity, Dyslipidemia
Status
Completed
Phase
Not Applicable
Locations
Cameroon
Study Type
Interventional
Intervention
IGOB131
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Weight loss, Antiobesity, Metabolic syndrome, Leptin
Eligibility Criteria
Inclusion Criteria:
- BMI>26
Exclusion Criteria:
- Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers
Sites / Locations
- Laboratory of Nutrition & Nutritional Biochemistry
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
1
Arm Description
Compare active to placebo
Outcomes
Primary Outcome Measures
Weight change
Secondary Outcome Measures
Change in blood lipids and hormone levels
Full Information
NCT ID
NCT00645775
First Posted
March 25, 2008
Last Updated
March 25, 2008
Sponsor
Gateway Health Alliance
Collaborators
University of Yaounde
1. Study Identification
Unique Protocol Identification Number
NCT00645775
Brief Title
Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome
Official Title
The Efficacy of Irvingia Gabonensis (Bush Mango) in the Management of Overweight, Obesity and Metabolic Syndrome in Cameroon.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gateway Health Alliance
Collaborators
University of Yaounde
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity, Dyslipidemia
Keywords
Weight loss, Antiobesity, Metabolic syndrome, Leptin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Compare active to placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
IGOB131
Intervention Description
Comparison of 250 mg per day of Irvingia gabonensis to placebo
Primary Outcome Measure Information:
Title
Weight change
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in blood lipids and hormone levels
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI>26
Exclusion Criteria:
Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius E Oben, PhD
Organizational Affiliation
Gateway Health Alliances / University of Yaounde
Official's Role
Study Director
Facility Information:
Facility Name
Laboratory of Nutrition & Nutritional Biochemistry
City
Yaounde
State/Province
Centre
ZIP/Postal Code
BP812
Country
Cameroon
12. IPD Sharing Statement
Citations:
PubMed Identifier
19254366
Citation
Ngondi JL, Etoundi BC, Nyangono CB, Mbofung CM, Oben JE. IGOB131, a novel seed extract of the West African plant Irvingia gabonensis, significantly reduces body weight and improves metabolic parameters in overweight humans in a randomized double-blind placebo controlled investigation. Lipids Health Dis. 2009 Mar 2;8:7. doi: 10.1186/1476-511X-8-7.
Results Reference
derived
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Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome
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