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CompletedNCT04079322Updated Feb 27, 2020

Iron Absorption and Exercise

An interventional study of Meal in Iron-deficiency and Iron Deficiency Anemia, sponsored by Florida State University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-02-27.

Sponsored by Florida State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Sex
All
01

Study summary

Iron is a nutritionally essential mineral required for optimal physical and cognitive performance. Endurance exercise often leads to declines in iron status; however, the reason for the decline is not known. The primary objective of the proposed study is to determine the effects of an acute bout of strenuous endurance exercise on iron absorption and status and markers of inflammation in human volunteers. The investigators hypothesize that an acute bout of strenuous endurance exercise, compared to rest, will reduce iron absorption, resulting in diminished iron status, and that reduced iron absorption will be negatively associated with markers of inflammation. A secondary objective is to monitor iron status throughout a season of competition.

02

Conditions studied

  • Iron-deficiency
  • Iron Deficiency Anemia
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 31 is below the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Members of the Florida State University Cross Country team
  • Refrain from using any pain-relievers (e.g., acetaminophen, nonsteroidal anti-inflammatory drugs such as aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product on the 2 study days
  • Refrain from using vitamin or mineral supplements on the study days

Exclusion criteria

Exclusion Criteria:

  • Musculoskeletal injury that compromise the ability to exercise
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Exercise

    During the exercise arm, volunteers will complete a planned workout, as prescribed by the coach. The workout will be designed to be strenuous and induce an inflammatory response.

    Other: Meal

  • Experimental
    Rest

    The rest arm will be coordinated with a planned non-workout day, as prescribed by the coach, where volunteers are either scheduled to not run or go for an easy recovery run (\<6 miles at a self-described "easy" pace) later in the afternoon.

    Other: Meal

Interventions

  • OtherMeal

    Participants will consume a meal containing a stable iron isotope following exercise or rest.

06

What researchers measure

Primary outcomes

  1. Change in fractional iron absorption

    Stable iron isotopes

    Time frame: Red blood cells collected on day 0 and day 14

Secondary outcomes

  1. Change in concentration of ferritin in ng/mL

    Blood measure

    Time frame: Day 0 and day 14

  2. Change in concentration of soluble transferrin receptor in nmol/L

    Blood measure

    Time frame: Day 0 and day 14

  3. Change in concentration of hemoglobin in g/L

    Blood measure

    Time frame: Day 0 and day 14

  4. Change in concentration of hematocrit as %

    Blood measure

    Time frame: Day 0 and day 14

  5. Change in concentration of hepcidin in ng/mL

    Blood measure

    Time frame: Day 0 and day 14

  6. Change in concentration of IL-6 in pg/mL

    Blood measure

    Time frame: Day 0 and day 14

07

Study locations

1 site
  • Florida State University
    Tallahassee, Florida 32306, United States
08

References and documents

Publications

  • Barney DE, Ippolito JR, Berryman CE, Hennigar SR. A Prolonged Bout of Running Increases Hepcidin and Decreases Dietary Iron Absorption in Trained Female and Male Runners. J Nutr. 2022 Sep 6;152(9):2039-2047. doi: 10.1093/jn/nxac129. PubMed 35661896 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04079322
Lead sponsor
Florida State University
Responsible party
Stephen R. Hennigar, Ph.D. (Assistant Professor, Florida State University) — Principal investigator
First posted
Sep 6, 2019
Start date
Aug 22, 2019
Primary completion
Dec 4, 2019
Completion
Dec 4, 2019
Last update
Feb 27, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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