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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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.

Responsible Party:	Pr. Julius Oben, CSO, Gateway Health Alliances
ClinicalTrials.gov Identifier:	NCT00645775 History of Changes
Other Study ID Numbers:	GHAIGOB131CT
First Posted:	March 28, 2008
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:

Syndrome; Obesity; Metabolic Syndrome X; Dyslipidemias; Disease; Pathologic Processes; Overnutrition; Nutrition Disorders	Overweight; Body Weight; Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders