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This study will measure nonheme iron absorption from each of the 7 daily MyPyramid menus. Such measurements will confirm whether modifications are needed to meet dietary iron recommendations and will provide data useful for validation algorithms to calculate dietary iron bioavailability.
Nonheme iron absorption is measured with 59Fe tracer added to a 1-day menu, with iron retention detected two weeks later in a whole body scintillation counter. Each subject has iron absorption measured from each of 7 1-d menus formulated to meet the US dietary guidelines (MyPyramid menus), with the order of menus randomly assigned. Each subject participates for 14 wk to test all 7 menus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyPyramid Menu Days 1-7 | Experimental | Iron absorption measured from one of the 7 different USDA MyPyramid menus for 1 day each, in randomized order for each subject, separated by 2 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Pyramid menu days 1, 2, 3, 4, 5, 6 or 7 | Behavioral | Iron absorption measured from one of seven different menus fed for 1 day each, in randomized order for each subject, with feedings separated by 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nonheme Iron Absorption | Absorption was estimated from whole body retention of a Iron-59 radiotracer, 2 weeks after consuming a menu labeled with the isotope, then normalized to a ferritin of 15 nanogram/milliLiter (ng/mL) | 2 weeks (wks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet R Hunt, PhD | USDA Grand Forks Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA Grand Forks Human Nutrition Research Center | Grand Forks | North Dakota | 58202 | United States |
154 applied,(47 applied too late, 30 did not meet inclusion criteria and 52 refused participation) 25 screened,4 excluded (3 did not pass screen and 1 refused participation), 5 alternates
Participants recruited from the Grand Forks, North Dakota community in September 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | MyPyramid Menus | USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | MyPyramid Menus | USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nonheme Iron Absorption | Absorption was estimated from whole body retention of a Iron-59 radiotracer, 2 weeks after consuming a menu labeled with the isotope, then normalized to a ferritin of 15 nanogram/milliLiter (ng/mL) | Analysis was per protocol | Posted | Log Mean | Standard Deviation | percentage of nonheme Iron absorbed | 2 weeks (wks) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MyPyramid Menus | USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenda Ling | United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center | 701-795-8300 | brenda.ling@ars.usda.gov |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 16 |
| 0 |
| 16 |
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