ObesityNCT00526682
The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids
A study testing Irvingia/cissus combo in people with Obesity and Overweight, run by Gateway Health Alliance.
Trial summary
Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight management and related conditions. This study set out to investigate if a combination of the two could have additional benefits to overweight and obese people. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Dyslipidemia
- What is being tested?
- Irvingia/cissus combo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI>26kg/m2
Who cannot join
- Diabetics
- Pregnant and lactating
- Subjects on any other weight loss program
- Following any specific low calorie diet
About this study
Official title: The Effect of Combining Cissus Quadrangularis and Irvingia Gabonensis on Obesity and Obesity Related Diseases
Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight management and related conditions. This study set out to investigate if a combination of the two could have additional benefits to overweight and obese people.
Read the detailed description
To assess and compare the effects of administration of Cissus quadrangularis (Linn) and a Cissus quadrangularis /Irvingia gabonensis combination on body weight blood pressure, fasting blood glucose, plasma total and LDL cholesterol in 72 overweight and obese subjects.
The study was a 10 week randomized, double-blind, placebo-controlled design, involving 72 obese or overweight participants. Participants were randomly divided into three groups (24 participants/ group):
Group 1 - Placebo; Group 2 - Cissus quadrangularis (CQ); Group 3 - Cissus quadrangularis and Irvingia gabonensis (CQ-IG).
The placebo (250mg) or active formulations ((150 mg CQ and 250 mg CQ-IG) were administered twice daily before meals. Weight as well as fasting blood was taken at baseline, and at 4, 8 and 10 weeks.
No major dietary changes or exercises were suggested during the study.
- Conditions
- Obesity, Overweight, Dyslipidemia
- Being tested
- Irvingia/cissus combo
- Keywords
- Antiobesity, Weight loss
- Medical subject headings
- Obesity, Overweight, Dyslipidemias, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irvingia/cissus comboDietary supplement
Also called Irvingia cissus combo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Comparison of actives for synergy Receives: Dietary Supplement: Irvingia/cissus combo |
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)
Blood lipids Body fat Fasting blood glucose
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 posted10 Sep 2007 (estimated)
- Study startJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gateway Health Alliance
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Julius E OBEN, PhD, Principal investigator, University of Yaounde 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526682
- Sponsor's protocol ID
- GHACT010
- Status last verified
- Sep 2007
- First submitted
- 6 Sep 2007
- Last updated
- 10 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combining Cissus Quadrangularis and Irvingia Gabonensis on Obesity and Obesity Related Diseases
- ClinicalTrials.gov ID
- NCT00526682
- Acronym / sponsor ID
- GHACT010
- Conditions
- Obesity, Overweight, Dyslipidemia
- Keywords
- Antiobesity, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gateway Health AllianceIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Apr 2007 (actual)
- First posted
- 10 Sep 2007 (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.
Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight management and related conditions. This study set out to investigate if a combination of the two could have additional benefits to overweight and obese people.
Detailed description
To assess and compare the effects of administration of Cissus quadrangularis (Linn) and a Cissus quadrangularis /Irvingia gabonensis combination on body weight blood pressure, fasting blood glucose, plasma total and LDL cholesterol in 72 overweight and obese subjects.
The study was a 10 week randomized, double-blind, placebo-controlled design, involving 72 obese or overweight participants. Participants were randomly divided into three groups (24 participants/ group):
Group 1 - Placebo; Group 2 - Cissus quadrangularis (CQ); Group 3 - Cissus quadrangularis and Irvingia gabonensis (CQ-IG).
The placebo (250mg) or active formulations ((150 mg CQ and 250 mg CQ-IG) were administered twice daily before meals. Weight as well as fasting blood was taken at baseline, and at 4, 8 and 10 weeks.
No major dietary changes or exercises were suggested during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Irvingia/cissus comboComparison of actives for synergy |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI>26kg/m2
Key exclusion criteria (4 listed)
- Diabetics
- Pregnant and lactating
- Subjects on any other weight loss program
- Following any specific low calorie diet
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 |
|---|---|---|
| Irvingia/cissus comboAlso: Irvingia cissus combo | Dietary supplement | 1 |
Primary outcome
Weight change
Time frame: 10 weeks
1 secondary outcome
Blood lipids Body fat Fasting blood glucose
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 10 Sep 2007.
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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 principal investigator
University of Yaounde 1
Questions about this trial
What is this clinical trial studying?
A study testing Irvingia/cissus combo in people with Obesity and Overweight, run by Gateway Health Alliance.
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 4 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 10 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
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 10 Sep 2007.