Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to identify markers of daily whole grain oat and whole grain wheat intake in humans.
The aim of this study is to identify compounds that are found in blood and urine and are derived from repeated daily consumption of whole grain oat or whole grain wheat intake so that epidemiological studies can be conducted to provide more accurate associations between whole grain intake and health.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Volunteers will consume a diet in which all grain foods are made from refined grains. |
|
| Low Whole Grain Oat Diet | Experimental | Volunteers will consume a diet with a low level of whole grain oat incorporated into some of the foods. |
|
| High Whole Grain Oat Diet | Experimental | Volunteers will consume a diet with a high level of whole grain oat incorporated into some of the foods. |
|
| Low Whole Grain Wheat Diet | Experimental | Volunteers will consume a diet with a low level of whole grain wheat incorporated into some of the foods. |
|
| High Whole Grain Wheat Diet | Experimental | Volunteers will consume a diet with a high level of whole grain wheat incorporated into some of the foods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Refined Grain Diet | Other | Subjects will be fed the average American diet except it will be free of whole grains |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 1 of Period 1 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 1 of Period 2 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 1 of Period 3 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 1 of Period 4 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 1 of Period 5 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of unknown urinary biomarkers of grain intake | Metabolomic analysis of urine samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 1, 8, and 15 of each of the 5 fifteen day diet periods |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA-ARS Beltsville Human Nutrition Research Center | Beltsville | Maryland | 20705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41423132 | Derived | Li Y, Novotny JA, Baer D, Hu Y, Sun Q, Zhang S, Sang S. Betainized metabolites as biomarkers of whole grain wheat, not oat: insights from controlled crossover pharmacokinetic and daily feeding studies. Am J Clin Nutr. 2026 Feb;123(2):101139. doi: 10.1016/j.ajcnut.2025.101139. Epub 2025 Dec 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low Whole Grain Oat Diet | Other | Subjects will be fed the average American diet with addition of a low level of whole grain oats |
|
| High Whole Grain Oat Diet | Other | Subjects will be fed the average American diet with addition of a high level of whole grain oats |
|
| Low Whole Grain Wheat Diet | Other | Subjects will be fed the average American diet with addition of a low level of whole grain wheat |
|
| High Whole Grain Wheat Diet | Other | Subjects will be fed the average American diet with addition of a high level of whole grain wheat |
|
Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined |
| Day 8 of Period 1 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 8 of Period 2 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 8 of Period 3 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 8 of Period 4 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 8 of Period 5 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 15 of Period 1 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 15 of Period 2 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 15 of Period 3 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 15 of Period 4 (period = 15 days) |
| Identification of unknown blood biomarkers of grain intake | Metabolomic analysis of blood samples will be conducted; the selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight will be determined | Day 15 of Period 5 (period = 15 days) |
| Characterization of fecal microbiota |
Fecal samples will be analyzed for microbiota |
| Day 1, 8, and 15 of each of the 5 fifteen day diet periods |
| Blood Glucose | Fasting blood glucose will be measured in mg/dL | Day 1 and 15 of each of the 5 fifteen day diet periods |
| Blood Insulin | Fasting blood insulin will be measured in uIU/mL | Day 1 and 15 of each of the 5 fifteen day diet periods |
| Blood Triglycerides | Fasting blood triglycerides will be measured in mg/dL | Day 1 and 15 of each of the 5 fifteen day diet periods |
| Blood Non-Esterified Fatty Acids | Fasting blood non esterified fatty acids will be measured in mEQ/L | Day 1 and 15 of each of the 5 fifteen day diet periods |