Cognitive ChangeIONSport:BeefNCT04427852
Nutrition, Vision, and Cognition in Sport Study: Beef
A study testing 30 day Daily consumption of 1 serving of beef and 30 day Daily consumption of 1 serving of the vegatable protein source in people with Cognitive Change and Nutrient Deficiency, run by Texas A&M University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Nutrient Deficiency, Nutritional Anemia
- What is being tested?
- 30 day Daily consumption of 1 serving of beef and 30 day Daily consumption of 1 serving of the vegatable protein source
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 year old female
- Eumenorrheic
Who cannot join
- Neuroactive medications such as Ritalin, Adderall, antidepressants etc
- Dietary supplements
- Iron intake above 15mg/day
- Protein intake above 1.5 g/kg/day
- More than 1 mild concussion lifetime or 1 mild concussion within the last 12 months
- History of affective disorder
Show all 15Show fewer
- Visual impairments uncorrected by glasses
- Amenorrhea or dysmenorrhea
- Currently being treated for anemia
- >3 servings of beef per week
- <20 BMI or BMI >35
- Consume >100mg caffeine/day (>1 cup of coffee or soda)
- <1 hour/week physical activity, >4 hours/week vigorous activity
- Depression score >18 (Beck Depression Inventory)
- <20 Kcal/kg/day
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cognitive Change, Nutrient Deficiency, Nutritional Anemia, Visual Spatial Processing, Diet, Healthy, Diet; Deficiency
- Being tested
- 30 day Daily consumption of 1 serving of beef, 30 day Daily consumption of 1 serving of the vegatable protein source
- Medical subject headings
- Spatial Processing, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 day Daily consumption of 1 serving of beefDietary supplement
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.
30 day Daily consumption of 1 serving of the vegatable protein sourceDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 30 day Beef consumption | Experimental | One serving of beef is consumed each day for 30 days. Receives: Dietary Supplement: 30 day Daily consumption of 1 serving of beef |
| 30 day Veggie Patty consumption | Placebo comparator | 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. Receives: Dietary Supplement: 30 day Daily consumption of 1 serving of the vegatable protein source |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean NeuroTracker Speed Threshold over 300 trials
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.
Measured: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Maximal NeuroTracker Speed Threshold over 300 trials
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.
Measured: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Change in NeuroTracker Speed Threshold over 300 trials
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.
Measured: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Secondary outcomes (1)
Blood Markers of anemia
blood levels of B12, iron, CBCs, ferritin, hepcidin
Measured: Day 1 and Day 30 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start20 Jan 2020
- Primary completion31 Dec 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomized to either one serving of beef or a macronutrient equivalent "veggie patty" per day for 30 days.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven E.Riechman, PhD, MPH, Texas A&M University
- Investigators
- Steve Riechman, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427852
- Sponsor's protocol ID
- M1803347
- Acronym
- IONSport:Beef
- Status last verified
- Sep 2025
- First submitted
- 6 Jun 2020
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not share
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition, Vision, and Cognition in Sport Study: Beef
- ClinicalTrials.gov ID
- NCT04427852
- Acronym / sponsor ID
- IONSport:Beef / M1803347
- Conditions
- Cognitive Change, Nutrient Deficiency, Nutritional Anemia, Visual Spatial Processing, Diet, Healthy, Diet; Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be randomized to either one serving of beef or a macronutrient equivalent "veggie patty" per day for 30 days.
| Arm | Type | Receives |
|---|---|---|
| 30 day Beef consumption | Experimental | Dietary Supplement: 30 day Daily consumption of 1 serving of beefOne serving of beef is consumed each day for 30 days. |
| 30 day Veggie Patty consumption | Placebo comparator | Dietary Supplement: 30 day Daily consumption of 1 serving of the vegatable protein sourceOne 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 year old female
- Eumenorrheic
Key exclusion criteria (15 listed)
- Neuroactive medications such as Ritalin, Adderall, antidepressants etc
- Dietary supplements
- Iron intake above 15mg/day
- Protein intake above 1.5 g/kg/day
- More than 1 mild concussion lifetime or 1 mild concussion within the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 day Daily consumption of 1 serving of beefBeef 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. | Dietary supplement | 30 day Beef consumption |
| 30 day Daily consumption of 1 serving of the vegatable protein sourceVeggie 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. | Dietary supplement | 30 day Veggie Patty consumption |
Primary outcome
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.
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.
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.
1 secondary outcome
Blood Markers of anemia
Time frame: Day 1 and Day 30 of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No. Will not share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Riechman, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 day Daily consumption of 1 serving of beef and 30 day Daily consumption of 1 serving of the vegatable protein source in people with Cognitive Change and Nutrient Deficiency, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean NeuroTracker Speed Threshold over 300 trials (time frame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.