The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids
Primary Purpose
Obesity, Overweight, Dyslipidemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Irvingia/cissus combo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Antiobesity, Weight loss
Eligibility Criteria
Inclusion Criteria:
- BMI>26kg/m2
Exclusion Criteria:
- Diabetics
- Pregnant and lactating
- Subjects on any other weight loss program
- Following any specific low calorie diet
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Comparison of actives for synergy
Outcomes
Primary Outcome Measures
Weight change
Secondary Outcome Measures
Blood lipids Body fat Fasting blood glucose
Full Information
NCT ID
NCT00526682
First Posted
September 6, 2007
Last Updated
September 6, 2007
Sponsor
Gateway Health Alliance
1. Study Identification
Unique Protocol Identification Number
NCT00526682
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gateway Health Alliance
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Dyslipidemia
Keywords
Antiobesity, Weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Comparison of actives for synergy
Intervention Type
Dietary Supplement
Intervention Name(s)
Irvingia/cissus combo
Other Intervention Name(s)
Irvingia cissus combo
Primary Outcome Measure Information:
Title
Weight change
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Blood lipids Body fat Fasting blood glucose
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI>26kg/m2
Exclusion Criteria:
Diabetics
Pregnant and lactating
Subjects on any other weight loss program
Following any specific low calorie diet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julius E OBEN, PhD
Organizational Affiliation
University of Yaounde 1
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids
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