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| Name | Class |
|---|---|
| Kellogg Company | INDUSTRY |
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The objectives of this study are the following: 1) to determine the effect of daily consumption of whole grain barley for six week on risk factors of cardiovascular disease compared to a diet low in whole grains, and 2) to compare the effects of daily consumption of whole grain barley to those of whole grain oats for six weeks to determine if the response to these two grains is different.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Grain Barley Diet | Experimental | A controlled diet containing at least 4 daily servings of whole grain barley. |
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| Whole Grain Oats Diet | Active Comparator | A diet containing at least 4 servings of whole grain oats. |
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| Low Whole Grain Diet | Other | A control diet containing 0.7 daily servings of whole grain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily ingestion of whole grain barley and oats | Other | Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats. After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast. During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state. |
| Measure | Description | Time Frame |
|---|---|---|
| Meal Tolerance Assessment | Subjects will provide a baseline blood sample at 15 minutes and 5 minutes prior to consuming a test meal. Subjects will then consume a high fat breakfast of foods such as eggs, buttered English muffins, and donuts. Blood samples will be collected 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 360, and 420 min following ingestion of the test meal. Measurements will be made for serum triglyceride area under the curve, serum cholesterol, insulin, glucose, and plasma apo B48. | 7 hours |
| Biomarkers of cardiovascular risk | Fibrinogen, factor VII, blood pressure, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, Lp(a), and lipoprotein size. | After a 12 hour fast |
| Biomarkers of oxidative stress | Nitrites and nitrates, malondialdehyde, lipid hydroperoxides, ox-LDL, resistance of LDL to Cu2+-induced oxidation, FRAP, glutathione, glutathione-S-transferase, super oxide dismutase, PON-1, betaine, homocysteine, total thiols, urinary isoprostanes. | After 6 weeks of feeding |
| Biomarkers of inflammation | C-reactive protein (CRP), IL-6, IL-8, IL-10, IL-18, TNFα, matrix metalloproteinases (MMP-2, MMP-9), e-Selectin, ICAM, VCAM | After 6 weeks of controlled feeding |
| Biomarkers of glucoregulatory control | Glycated apolipoprotein B, hemoglobin A1c, fructosamine, insulin, glucose, leptin, adiponectin | After 6 weeks of feeding |
| Measure | Description | Time Frame |
|---|---|---|
| Genotype testing | Blood will be used to test for genetic traits that may influence nutrient metabolism and also traits reflecting the mechanisms that may be influenced by the intervention. | After 6 weeks of controlled feeding |
| Microarray and targeted gene expression testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet A Novotny, PhD | USDA Beltsville Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA Beltsville Human Nutrition Research Center | Beltsville | Maryland | 20705 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Blood samples will be used to test how the intervention affects gene expression. Global gene expression will be performed for a complete survey of the RNA response to the intervention. Targeted gene expression will be performed to confirm the findings of the global gene expression analysis. |
| After 6 weeks of controlled feeding |