- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526682
The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids
The Effect of Combining Cissus Quadrangularis and Irvingia Gabonensis on Obesity and Obesity Related Diseases
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI>26kg/m2
Exclusion Criteria:
- Diabetics
- Pregnant and lactating
- Subjects on any other weight loss program
- Following any specific low calorie diet
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Comparison of actives for synergy
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weight change
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood lipids Body fat Fasting blood glucose
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julius E Oben, PhD, University of Yaounde 1
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHACT010
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