Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, Pomegranate, Biomarkers, Antioxidant
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 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.
Interventions
DIETARY_SUPPLEMENTPomegranate Juice
Group A drinks 8 oz. pomegranate juice/day for 12 weeks
DIETARY_SUPPLEMENTPlacebo Juice
Group B drinks 8 oz. placebo juice/day for 12 weeks
Sponsors
POM Wonderful LLC
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change of oxidant stress and lipid oxidation | baseline, week 6, week 12 |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | baseline, week 6, week 12 |
| High Sensitivity C-reactive protein HsCRP | baseline, week 6, week 12 |
Countries
United States
Outcome results
None listed