Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 35 - 70 |
Updated: | 4/21/2016 |
Start Date: | April 2008 |
End Date: | November 2010 |
Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load
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.
affects the body through the measurement of specific biomarkers, which are indicators of
health.
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 of health, will be measured throughout the study. They are present in
blood and urine. The placebo is a juice that is not made from pomegranates, but resembles
pomegranate juice in color and taste. Eating pomegranates has been shown to have a positive
impact on certain biomarkers. Recent studies have shown that biomarkers can be indicators of
general health. The investigators want to know if drinking pomegranate juice daily for 12
weeks is effective at improving a variety of biomarkers in diabetic adults.
body. Participants will be asked to drink 8 oz. of juice daily for 12 weeks. Biomarkers,
which are indicators of health, will be measured throughout the study. They are present in
blood and urine. The placebo is a juice that is not made from pomegranates, but resembles
pomegranate juice in color and taste. Eating pomegranates has been shown to have a positive
impact on certain biomarkers. Recent studies have shown that biomarkers can be indicators of
general health. The investigators want to know if drinking pomegranate juice daily for 12
weeks is effective at improving a variety of biomarkers in diabetic adults.
Inclusion Criteria:
- 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 Criteria:
- 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
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