Nonheme Iron Absorption
Conditions
Keywords
iron absorption, iron requirements, dietary guidelines, MyPyramid
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMy Pyramid menu days 1, 2, 3, 4, 5, 6 or 7
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
Sponsors
USDA Grand Forks Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women 21 to 50 years old
Exclusion criteria
* Anemia, * High blood pressure, * Disorders affecting iron absorption or retention, * Underlying medical conditions, * Taking medication other than birth control pills or hormone replacement therapy, * Pregnancy, * Daily use of analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nonheme Iron Absorption | 2 weeks (wks) | 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) |
Countries
United States
Participant flow
Recruitment details
Participants recruited from the Grand Forks, North Dakota community in September 2007.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| MyPyramid Menus USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | MyPyramid Menus |
|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
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)
Time frame: 2 weeks (wks)
Population: Analysis was per protocol
| Arm | Measure | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|
| MyPyramid Menu | Nonheme Iron Absorption | 2.31 percentage of nonheme Iron absorbed | Standard Deviation 0.61 |