- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04079322
Iron Absorption and Exercise
February 25, 2020 updated by: Stephen R. Hennigar, Ph.D., Florida State University
Fractional Iron Absorption in Response to an Acute Bout of Exercise
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
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
-
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Florida
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Tallahassee, Florida, United States, 32306
- Florida State University
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-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Participants will consume a meal containing a stable iron isotope following exercise or rest.
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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.
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Participants will consume a meal containing a stable iron isotope following exercise or rest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fractional iron absorption
Time Frame: Red blood cells collected on day 0 and day 14
|
Stable iron isotopes
|
Red blood cells collected on day 0 and day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in concentration of ferritin in ng/mL
Time Frame: Day 0 and day 14
|
Blood measure
|
Day 0 and day 14
|
Change in concentration of soluble transferrin receptor in nmol/L
Time Frame: Day 0 and day 14
|
Blood measure
|
Day 0 and day 14
|
Change in concentration of hemoglobin in g/L
Time Frame: Day 0 and day 14
|
Blood measure
|
Day 0 and day 14
|
Change in concentration of hematocrit as %
Time Frame: Day 0 and day 14
|
Blood measure
|
Day 0 and day 14
|
Change in concentration of hepcidin in ng/mL
Time Frame: Day 0 and day 14
|
Blood measure
|
Day 0 and day 14
|
Change in concentration of IL-6 in pg/mL
Time Frame: Day 0 and day 14
|
Blood measure
|
Day 0 and day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (ACTUAL)
August 22, 2019
Primary Completion (ACTUAL)
December 4, 2019
Study Completion (ACTUAL)
December 4, 2019
Study Registration Dates
First Submitted
August 12, 2019
First Submitted That Met QC Criteria
September 4, 2019
First Posted (ACTUAL)
September 6, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 27, 2020
Last Update Submitted That Met QC Criteria
February 25, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.28633
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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