Status:
COMPLETED
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
POM Wonderful LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-70 years
Phase:
NA
Brief Summary
This is a research study designed to look at how pomegranate juice (or a placebo juice) affects the body through the measurement of specific biomarkers, which are indicators of health.
Detailed Description
This research study will evaluate how pomegranate juice (or a placebo juice) affects the body. Participants will be asked to drink 8 oz. of juice daily for 12 weeks. Biomarkers, which are indicators o...
Eligibility Criteria
Inclusion
- Able to speak and read English
- Have a diagnosis of Type II Diabetes Mellitus and currently being treated with oral medication
- Have an HbA1C level ≤9.0% at Screening
- Have an hsCRP level ≥ 1.0 at Screening
- 35 - 70 years old (inclusive)
- Non-smokers
- Willing to maintain his/her normal activity and eating patterns for the duration of the study
- Willing to maintain his/her normal diet for the duration of the study but avoid anti-oxidant rich foods and pomegranate juice (other than what is dispensed to them)
Exclusion
- Allergy to pomegranates
- Currently using insulin
- Currently taking steroidal drugs
- HIV positive or AIDS
- Chronic infectious disease
- Recent (within 2 weeks of screening) cold/flu, inflammatory illness, or flare-up of gout
- Cancer treated within the past two years
- Participation in a therapeutic research study within 30 days of baseline
- Women who are pregnant, lactating, or planning to become pregnant during the study period
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00668954
Start Date
April 1 2008
End Date
November 1 2010
Last Update
July 31 2015
Active Locations (1)
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1
University of Colorado Denver Center for Human Nutrition
Denver, Colorado, United States, 80220