Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome - Full Text View

Sponsor:	Gateway Health Alliance
Collaborator:	University of Yaounde
Information provided by:	Gateway Health Alliance
ClinicalTrials.gov Identifier:	NCT00645775

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Obesity

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
1: Placebo Comparator Compare active to placebo	Dietary Supplement: IGOB131 Comparison of 250 mg per day of Irvingia gabonensis to placebo

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, Centre
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 National Clinical Trials Identifier (NCT ID):

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.

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

Keywords provided by Gateway Health Alliance:

Weight loss
Antiobesity
Metabolic syndrome
Leptin

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Metabolic Diseases
Pathologic Processes
Disease

Syndrome
Nutrition Disorders
Overweight
Overnutrition
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010