Nutrition, Vision, and Cognition in Sport Study: Beef (IONSport:Beef)

September 23, 2025 updated by: Steven E.Riechman, PhD, MPH, Texas A&M University
The purpose of this study is to determine whether a 30 day beef intervention can improve peak cognitive performance in young, normally menstruating adult women. The control group will consume a daily portion of macronutrient equivalent vegetable source of protein.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of the Nutrition, Vision, and Cognition in Health Sport: Beef (IONSport-Beef) study is to conduct a randomized controlled trial to evaluate beef as a nutritional intervention to optimize visual cognitive training performance in generally healthy, normally menstruating women. Female subjects of reproductive age (18-40) will be randomly placed in one of two dietary treatment groups: one serving of beef per day for 30 days or a non-meat protein replacement control. Cognitive performance will be measured in 15 training sessions over 10 days using the sophisticated NeuroTracker™ CORE (NT) 3-Dimensional (3D) software program. It is hypothesized that women consuming 1 serving of beef per day for 30 days will have the highest plasma levels of the beef rich nutrients and demonstrate the highest visual cognitive performance and improvement as compared to the no beef control.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • College Station, Texas, United States, 77845
        • Texas A&M University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 18-40 year old female
  2. Eumenorrheic

Exclusion Criteria:

  1. Neuroactive medications such as Ritalin, Adderall, antidepressants etc
  2. Dietary supplements
  3. Iron intake above 15mg/day
  4. Protein intake above 1.5 g/kg/day
  5. More than 1 mild concussion lifetime or 1 mild concussion within the last 12 months
  6. History of affective disorder
  7. Visual impairments uncorrected by glasses
  8. Amenorrhea or dysmenorrhea
  9. Currently being treated for anemia
  10. >3 servings of beef per week
  11. <20 BMI or BMI >35
  12. Consume >100mg caffeine/day (>1 cup of coffee or soda)
  13. <1 hour/week physical activity, >4 hours/week vigorous activity
  14. Depression score >18 (Beck Depression Inventory)
  15. <20 Kcal/kg/day

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 30 day Beef consumption
One serving of beef is consumed each day for 30 days.
Dietary supplement: 30 day Daily consumption of 1 serving of beef
Beef patty will replace one of the participants protein servings each day for 30 days. Each serving is 114 grams of 90% lean ground sirloin given to participants as an uncooked frozen patty.
Placebo Comparator: 30 day Veggie Patty consumption
One serving (1 patty) of a vegetable based protein source is consumed each day for 30 days. The weight of the food, total calories, grams of protein, and total fat are the same as the beef serving.
Dietary supplement: 30 day Daily consumption of 1 serving of the vegatable protein source
Veggie patty will replace one of the participants protein servings each day for 30 days. No beef will be consumed during this period. The veggie patty is commercially available Morningstar veggie burger and is given to participants in commercial packaging as a frozen precooked patty.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean NeuroTracker Speed Threshold over 300 trials
Time Frame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Cognitive Performance on the Neurotracker 3D software program that includes 20 trials in each session. Particpants will track 4 of 8 balls with increasing speed if successful and slower if unsuccessful.The speed threshold is optimized performance for that session. Across the 15 sessions, mean speed threshold is defined as the average speed threshold for the 15 sessions.
15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Maximal NeuroTracker Speed Threshold over 300 trials
Time Frame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Cognitive Performance on the Neurotracker 3D software program that includes 20 trials in each session. Particpants will track 4 of 8 balls with increasing speed if successful and slower if unsuccessful. The speed threshold is optimized performance for that session. Across the 15 sessions, maximal speed threshold is defined as the highest speed threshold.
15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Change in NeuroTracker Speed Threshold over 300 trials
Time Frame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Cognitive Performance on the Neurotracker 3D software program that includes 20 trials in each session. Particpants will track 4 of 8 balls with increasing speed if successful and slower if unsuccessful. The speed threshold is optimized performance for that session. Across the 15 sessions, change in speed threshold is defined as the difference between the mean of the first three sessions and the mean of the last three sessions.
15 sessions (300 trials) over 10 days at the end of the nutritional intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Markers of anemia
Time Frame: Day 1 and Day 30 of the intervention
blood levels of B12, iron, CBCs, ferritin, hepcidin
Day 1 and Day 30 of the intervention

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas A&M University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steve Riechman, PhD, Texas A&M University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M1803347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will not share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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