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Iron Absorption and Exercise

Primary Purpose

Iron-deficiency, Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron-deficiency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • Musculoskeletal injury that compromise the ability to exercise

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise

Rest

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in fractional iron absorption
Stable iron isotopes

Secondary Outcome Measures

Change in concentration of ferritin in ng/mL
Blood measure
Change in concentration of soluble transferrin receptor in nmol/L
Blood measure
Change in concentration of hemoglobin in g/L
Blood measure
Change in concentration of hematocrit as %
Blood measure
Change in concentration of hepcidin in ng/mL
Blood measure
Change in concentration of IL-6 in pg/mL
Blood measure

Full Information

First Posted
August 12, 2019
Last Updated
February 25, 2020
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT04079322
Brief Title
Iron Absorption and Exercise
Official Title
Fractional Iron Absorption in Response to an Acute Bout of Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
December 4, 2019 (Actual)
Study Completion Date
December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Rest
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Meal
Intervention Description
Participants will consume a meal containing a stable iron isotope following exercise or rest.
Primary Outcome Measure Information:
Title
Change in fractional iron absorption
Description
Stable iron isotopes
Time Frame
Red blood cells collected on day 0 and day 14
Secondary Outcome Measure Information:
Title
Change in concentration of ferritin in ng/mL
Description
Blood measure
Time Frame
Day 0 and day 14
Title
Change in concentration of soluble transferrin receptor in nmol/L
Description
Blood measure
Time Frame
Day 0 and day 14
Title
Change in concentration of hemoglobin in g/L
Description
Blood measure
Time Frame
Day 0 and day 14
Title
Change in concentration of hematocrit as %
Description
Blood measure
Time Frame
Day 0 and day 14
Title
Change in concentration of hepcidin in ng/mL
Description
Blood measure
Time Frame
Day 0 and day 14
Title
Change in concentration of IL-6 in pg/mL
Description
Blood measure
Time Frame
Day 0 and day 14

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Musculoskeletal injury that compromise the ability to exercise
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35661896
Citation
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.
Results Reference
derived

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Iron Absorption and Exercise

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