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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00526682
Other study ID # GHACT010
Secondary ID
Status Completed
Phase N/A
First received September 6, 2007
Last updated September 6, 2007
Start date January 2007
Est. completion date April 2007

Study information

Verified date September 2007
Source Gateway Health Alliance
Contact n/a
Is FDA regulated No
Health authority Cameroon: Ministry of Public Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Irvingia/cissus combo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gateway Health Alliance

Outcome

Type Measure Description Time frame Safety issue
Primary Weight change 10 weeks
Secondary Blood lipids Body fat Fasting blood glucose 10 weeks
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