Effect of Irvingia Gabonensis (Bush Mango)on Parameters A... | NCT00645775

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

NCT00645775

Sponsor

Gateway Health Alliance

Status

Completed

Last Update Posted

Mar 28, 2008Estimated

Enrollment

102Actual

Phase

Not Applicable

Conditions

Metabolic Syndrome
Obesity
Dyslipidemia

Interventions

IGOB131

Countries

Cameroon

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Mar 25, 2008

First Submission Date that Met QC Criteria

Mar 25, 2008

First Posted Date

Mar 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2008

Last Update Posted Date

Mar 28, 2008Estimated

Name	Class
University of Yaounde	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Compare active to placebo	Dietary Supplement: IGOB131

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IGOB131	Dietary Supplement	Comparison of 250 mg per day of Irvingia gabonensis to placebo	1

Measure	Description	Time Frame
Weight change		10 weeks

Measure	Description	Time Frame
Change in blood lipids and hormone levels		10 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI>26

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julius E Oben, PhD	Gateway Health Alliances / University of Yaounde	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory of Nutrition & Nutritional Biochemistry		Yaoundé	Centre Region	BP812	Cameroon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19254366	Derived	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.

ID	Term
D024821	Metabolic Syndrome
D009765	Obesity
D050171	Dyslipidemias
D015431	Weight Loss

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases