NCT04427852

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

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

Study Start

First participant enrolled

January 20, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

June 6, 2020

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    15 sessions (300 trials) over 10 days at the end of the nutritional intervention

Secondary Outcomes (1)

  • Blood Markers of anemia

    Day 1 and Day 30 of the intervention

Study Arms (2)

30 day Beef consumption

EXPERIMENTAL

One serving of beef is consumed each day for 30 days.

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.

Dietary Supplement: 30 day Daily consumption of 1 serving of the vegatable protein source

Interventions

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 Beef consumption

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.

30 day Veggie Patty consumption

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological female, normally menstruating
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • year old female
  • Eumenorrheic

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M University

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Spatial ProcessingMalnutrition

Condition Hierarchy (Ancestors)

Spatial BehaviorBehaviorNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Steve Riechman, PhD

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
note on masking: The title of the study presented to participants is "IONsport: Women and Protein" and the funding source is withheld to mask from participants our underlying hypothesis. It is open label in the sense that they know what they are eating.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study participants will be randomized to either one serving of beef or a macronutrient equivalent "veggie patty" per day for 30 days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 11, 2020

Study Start

January 20, 2020

Primary Completion

December 31, 2020

Study Completion

June 1, 2021

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Will not share

Locations