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| Name | Class |
|---|---|
| University of Washington | OTHER |
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The primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. This study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. Blood carotene levels will be measured before and after 28 days of supplementation. Preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. These biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement 1 | Active Comparator |
| |
| Supplement 2 | Active Comparator |
| |
| Food-based Intervention | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorophyll complex, Standard Process | Dietary Supplement | One capsule, twice daily with meals for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum carotenoid fraction concentrations between study arms | Following 28 day intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxidized LDL lipoproteins (oxLDL) | Following 28 day intervention | |
| Change in serum gamma-glutamyl transferase (GGT) | Following 28 day intervention | |
| Change in urinary isoprostanes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan D Bradley, ND, MPH | Bastyr University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bastyr University Clinical Research Center | Kenmore | Washington | 98028 | United States | ||
| University of Washington Clinical Research Center |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Betatene, sold as "Full Spectrum Carotenoid Complex" | Dietary Supplement | One capsule per day with meals for 28 days |
|
| Small carotenoid-rich meals | Other | Single carotenoid-enriched soup or salad serving eaten daily |
|
| Placebo | Other | Safflower oil-filled capsules, one twice daily with meals |
|
| Following 28 day intervention |
| Change in serum antioxidant capacity (ORAC) | Following 28 day intervention |
| Change in lipid profile (LDL, HDL, triglycerides) | Following 28 day intervention |
| Change in C-reactive protein (CRP) | Following 28 day intervention |
| Seattle |
| Washington |
| 98195 |
| United States |