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| Name | Class |
|---|---|
| POM Wonderful LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomegranate Juice | Active Comparator |
| |
| Placebo Juice (non-Pomegranate) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomegranate Juice | Dietary Supplement | Group A drinks 8 oz. pomegranate juice/day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of oxidant stress and lipid oxidation | baseline, week 6, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | baseline, week 6, week 12 | |
| High Sensitivity C-reactive protein HsCRP | baseline, week 6, week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James O. Hill, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Center for Human Nutrition | Denver | Colorado | 80220 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo Juice | Dietary Supplement | Group B drinks 8 oz. placebo juice/day for 12 weeks |
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