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Trial record 1 of 1 for:    NCT00645775
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Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
University of Yaounde
Information provided by:
Gateway Health Alliance
ClinicalTrials.gov Identifier:
NCT00645775
First received: March 25, 2008
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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 Intervention
Metabolic Syndrome
Obesity
Dyslipidemia
 Dietary Supplement: IGOB131

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gateway Health Alliance:

Primary Outcome Measures:
  • Weight change [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in blood lipids and hormone levels [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: November 2006
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Compare active to placebo
 Dietary Supplement: IGOB131
Comparison of 250 mg per day of Irvingia gabonensis to placebo
Other Name: IGOB131

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.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645775

Locations
Cameroon
Laboratory of Nutrition & Nutritional Biochemistry
Yaounde, Centre, Cameroon, BP812
Sponsors and Collaborators
Gateway Health Alliance
University of Yaounde
Investigators
Study Director: Julius E Oben, PhD Gateway Health Alliances / University of Yaounde
  More Information

No publications provided by Gateway Health Alliance

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pr. Julius Oben, CSO, Gateway Health Alliances
ClinicalTrials.gov Identifier: NCT00645775     History of Changes
Other Study ID Numbers: GHAIGOB131CT
Study First Received: March 25, 2008
Last Updated: March 25, 2008
Health Authority: Cameroon: Ministry of Public Health

Keywords provided by Gateway Health Alliance:
Weight loss
Antiobesity
Metabolic syndrome
Leptin

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 16, 2013