Trial Outcomes & Findings for Iron Bioavailability From MyPyramid Menus (NCT NCT00754234)
NCT ID: NCT00754234
Last Updated: 2018-07-02
Results Overview
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)
COMPLETED
NA
16 participants
2 weeks (wks)
2018-07-02
Participant Flow
Participants recruited from the Grand Forks, North Dakota community in September 2007.
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
Participant milestones
| Measure |
MyPyramid Menus
USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
MyPyramid Menus
USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Iron Bioavailability From MyPyramid Menus
Baseline characteristics by cohort
| Measure |
MyPyramid Menus
n=16 Participants
USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
|
|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 10 • n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 weeks (wks)Population: Analysis was per protocol
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)
Outcome measures
| Measure |
MyPyramid Menu
n=14 Participants
USDA MyPyramid menus for Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
|
|---|---|
|
Nonheme Iron Absorption
|
2.31 percentage of nonheme Iron absorbed
Standard Deviation 0.61
|
Adverse Events
MyPyramid Menus
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brenda Ling
United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place