Iron Bioavailability From MyPyramid Menus

This study has been completed.
Sponsor:
Information provided by:
USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00754234
First received: September 16, 2008
Last updated: June 1, 2011
Last verified: June 2011
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

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
Study First Received: September 16, 2008
Results First Received: December 30, 2008
Last Updated: June 1, 2011
Health Authority: United States: Federal Government

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014