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Tracking Information | |||||
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First Received Date † | September 6, 2007 | ||||
Last Updated Date | September 6, 2007 | ||||
Start Date † | January 2007 | ||||
Current Primary Outcome Measures † |
Weight change [ Time Frame: 10 weeks ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
Blood lipids Body fat Fasting blood glucose [ Time Frame: 10 weeks ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids | ||||
Official Title † | The Effect of Combining Cissus Quadrangularis and Irvingia Gabonensis on Obesity and Obesity Related Diseases | ||||
Brief 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. |
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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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||
Condition † |
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Intervention † | Dietary Supplement: Irvingia/cissus combo | ||||
Study Arms / Comparison Groups | Active Comparator: Comparison of actives for synergy | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 72 | ||||
Completion Date | April 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 19 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00526682 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Gateway Health Alliance | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Gateway Health Alliance | ||||
Verification Date | September 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |