Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antioxidant Effects of Pomegranate Juice Versus Placebo in Adults With Type 2 Diabetes Mellitus Following a Glucose Load

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Pomegranate Juice
* Dietary Supplement: Placebo Juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pomegranate Juice<br> | Dietary Supplement: Pomegranate Juice<br>* Group A drinks 8 oz. pomegranate juice/day for 12 weeks<br>|
| Placebo Comparator: Placebo Juice (non-Pomegranate)<br> | Dietary Supplement: Placebo Juice<br>* Group B drinks 8 oz. placebo juice/day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of oxidant stress and lipid oxidation |  | baseline, week 6, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | baseline, week 6, week 12 | 
| High Sensitivity C-reactive protein HsCRP |  | baseline, week 6, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Pomegranate, Biomarkers, Antioxidant