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Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00645775
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Sponsor:
Collaborator:
University of Yaounde
Information provided by:
Gateway Health Alliance

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Obesity Dyslipidemia Dietary Supplement: IGOB131 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Irvingia Gabonensis (Bush Mango) in the Management of Overweight, Obesity and Metabolic Syndrome in Cameroon.
Study Start Date : November 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2007

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
Compare active to placebo
 Dietary Supplement: IGOB131
Comparison of 250 mg per day of Irvingia gabonensis to placebo


Outcome Measures
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Primary Outcome Measures :
  1. Weight change [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Change in blood lipids and hormone levels [ Time Frame: 10 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI>26

Exclusion Criteria:

  • Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645775


Locations
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Cameroon
Laboratory of Nutrition & Nutritional Biochemistry
Yaounde, Centre, Cameroon, BP812
Sponsors and Collaborators
Gateway Health Alliance
University of Yaounde
Investigators
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Study Director: Julius E Oben, PhD Gateway Health Alliances / University of Yaounde
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pr. Julius Oben, CSO, Gateway Health Alliances
ClinicalTrials.gov Identifier: NCT00645775    
Other Study ID Numbers: GHAIGOB131CT
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: August 2006
Keywords provided by Gateway Health Alliance:
Weight loss
Antiobesity
Metabolic syndrome
Leptin
Additional relevant MeSH terms:
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Obesity
Metabolic Syndrome
Dyslipidemias
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders