NCT00645775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

March 28, 2008

Status Verified

August 1, 2006

Enrollment Period

4 months

First QC Date

March 25, 2008

Last Update Submit

March 25, 2008

Conditions

Metabolic SyndromeObesityDyslipidemia

Keywords

Weight lossAntiobesityMetabolic syndromeLeptin

Outcome Measures

Primary Outcomes (1)

  • Weight change

    10 weeks

Secondary Outcomes (1)

  • Change in blood lipids and hormone levels

    10 weeks

Study Arms (1)

1

PLACEBO COMPARATOR

Compare active to placebo

Dietary Supplement: IGOB131

Interventions

IGOB131DIETARY_SUPPLEMENT

Comparison of 250 mg per day of Irvingia gabonensis to placebo

1

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\>26

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Nutrition & Nutritional Biochemistry

Yaoundé, Centre Region, BP812, Cameroon

Location

Related Publications (1)

  • 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.

    PMID: 19254366DERIVED

MeSH Terms

Conditions

Metabolic SyndromeObesityDyslipidemiasWeight Loss

Interventions

IGOB131

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersBody Weight Changes

Study Officials

  • Julius E Oben, PhD

    Gateway Health Alliances / University of Yaounde

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

November 1, 2006

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

March 28, 2008

Record last verified: 2006-08

Locations

CA(1)