Iron Bioavailability From MyPyramid Menus

May 24, 2018 updated by: USDA Grand Forks Human Nutrition Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Dakota
      • Grand Forks, North Dakota, United States, 58202
        • USDA Grand Forks Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 weeks (wks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Grand Forks Human Nutrition Research Center

Investigators

  • Principal Investigator: Janet R Hunt, PhD, USDA Grand Forks Human Nutrition Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 16, 2008

First Posted (Estimate)

September 17, 2008

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

May 24, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GFHNRC003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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