NCT04079322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

August 22, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2019

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

August 12, 2019

Last Update Submit

February 25, 2020

Conditions

Iron-deficiencyIron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Change in fractional iron absorption

    Stable iron isotopes

    Red blood cells collected on day 0 and day 14

Secondary Outcomes (6)

  • Change in concentration of ferritin in ng/mL

    Day 0 and day 14

  • Change in concentration of soluble transferrin receptor in nmol/L

    Day 0 and day 14

  • Change in concentration of hemoglobin in g/L

    Day 0 and day 14

  • Change in concentration of hematocrit as %

    Day 0 and day 14

  • Change in concentration of hepcidin in ng/mL

    Day 0 and day 14

  • +1 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

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

Rest

EXPERIMENTAL

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

MealOTHER

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

ExerciseRest

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Musculoskeletal injury that compromise the ability to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (2)

  • Barney DE Jr, Cheung SN, Harris AR, Berryman CE, Hennigar SR. Dietary Intake and Diet Quality of Female and Male NCAA Division I Cross Country Runners from a Single University. Curr Dev Nutr. 2024 Oct 15;8(11):104475. doi: 10.1016/j.cdnut.2024.104475. eCollection 2024 Nov.

    PMID: 39610765DERIVED

  • 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.

    PMID: 35661896DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Meals

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 12, 2019

First Posted

September 6, 2019

Study Start

August 22, 2019

Primary Completion

December 4, 2019

Study Completion

December 4, 2019

Last Updated

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)