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Iron Bioavailability From MyPyramid Menus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754234
First Posted: September 17, 2008
Last Update Posted: June 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
USDA Grand Forks Human Nutrition Research Center
  Purpose
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.

Condition Intervention
Nonheme Iron Absorption Behavioral: My Pyramid menu days 1, 2, 3, 4, 5, 6 or 7

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Iron Bioavailability From MyPyramid Menus

Resource links provided by NLM:


Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Nonheme Iron Absorption [ Time Frame: 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)


Enrollment: 16
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MyPyramid Menu Days 1-7
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
Behavioral: My 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754234


Locations
United States, North Dakota
USDA Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58202
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
Principal Investigator: Janet R Hunt, PhD USDA Grand Forks Human Nutrition Research Center
  More Information

Responsible Party: Janet R Hunt, Ph.D., R.D. Research Nutritionist, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00754234     History of Changes
Other Study ID Numbers: GFHNRC003
First Submitted: September 16, 2008
First Posted: September 17, 2008
Results First Submitted: December 30, 2008
Results First Posted: June 2, 2009
Last Update Posted: June 14, 2011
Last Verified: June 2011

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
iron absorption
iron requirements
dietary guidelines
MyPyramid

Additional relevant MeSH terms:
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs