Metabolic SyndromeNCT00645775
Effect of Irvingia Gabonensis (Bush Mango)on Parameters Associated With Metabolic Syndrome
A study testing IGOB131 in people with Metabolic Syndrome and Obesity, run by Gateway Health Alliance at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity, Dyslipidemia
- What is being tested?
- IGOB131
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteCameroon
- Study dates
- Nov 2006to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI>26
Who cannot join
- Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Laboratory of Nutrition & Nutritional Biochemistry
Yaoundé, Centre Region, BP812
About this study
Official title: The Efficacy of Irvingia Gabonensis (Bush Mango) in the Management of Overweight, Obesity and Metabolic Syndrome in Cameroon.
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Obesity, Dyslipidemia
- Being tested
- IGOB131
- Keywords
- Weight loss, Antiobesity, Metabolic syndrome, Leptin
- Medical subject headings
- Metabolic Syndrome, Obesity, Dyslipidemias, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGOB131Dietary supplement
Comparison of 250 mg per day of Irvingia gabonensis to placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Compare active to placebo Receives: Dietary Supplement: IGOB131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Measured: 10 weeks
Secondary outcomes (1)
Change in blood lipids and hormone levels
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startNov 2006
- Primary completionMar 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gateway Health Alliance
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Yaounde
- Investigators
- Julius E Oben, PhD, Study director, Gateway Health Alliances / University of Yaounde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645775
- Sponsor's protocol ID
- GHAIGOB131CT
- Status last verified
- Aug 2006
- First submitted
- 25 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1186/1476-511X-8-7.
PubMed 19254366
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Irvingia Gabonensis (Bush Mango) in the Management of Overweight, Obesity and Metabolic Syndrome in Cameroon.
- ClinicalTrials.gov ID
- NCT00645775
- Acronym / sponsor ID
- GHAIGOB131CT
- Conditions
- Metabolic Syndrome, Obesity, Dyslipidemia
- Keywords
- Weight loss, Antiobesity, Metabolic syndrome, Leptin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gateway Health AllianceIndustry (pharma, biotech, devices)
- Collaborators
- University of Yaounde
- Study start
- Nov 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: IGOB131Compare active to placebo |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI>26
Key exclusion criteria (1 listed)
- Diabetics Pregnant and lactating Participating in any other weight reducing program Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGOB131Comparison of 250 mg per day of Irvingia gabonensis to placebo | Dietary supplement | 1 |
Primary outcome
Weight change
Time frame: 10 weeks
1 secondary outcome
Change in blood lipids and hormone levels
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2008.
- Derived from this study: PubMed 19254366Ngondi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julius E Oben, PhD study director
Gateway Health Alliances / University of Yaounde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGOB131 in people with Metabolic Syndrome and Obesity, run by Gateway Health Alliance at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00645775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2008.