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

Tracking Information

First Received Date ^ICMJE

March 25, 2008

Last Updated Date

March 25, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Weight change [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Efficacy of Irvingia Gabonensis (Bush Mango) in the Management of Overweight, Obesity and Metabolic Syndrome in Cameroon.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Metabolic Syndrome
Obesity
Dyslipidemia

Intervention ^ICMJE

Dietary Supplement: IGOB131

Study Arms / Comparison Groups

Placebo Comparator: Compare active to placebo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

102

Completion Date

April 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

BMI>26

Exclusion Criteria:

Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers

Gender

Both

Ages

19 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Cameroon

Administrative Information

NCT ID ^ICMJE

NCT00645775

Responsible Party

Pr. Julius Oben, CSO, Gateway Health Alliances

Study ID Numbers ^ICMJE

GHAIGOB131CT

Study Sponsor ^ICMJE

Gateway Health Alliance

Collaborators ^ICMJE

University of Yaounde

Investigators ^ICMJE

Study Director:

Julius E Oben, PhD

Gateway Health Alliances / University of Yaounde

Information Provided By

Gateway Health Alliance

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP