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
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