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

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: Unknown
• Conditions: Cognitive Change; Nutritional Anemia; Diet, Healthy; Nutrient Deficiency; Diet; Deficiency; Visual Spatial Processing; Dietary Deficiency; Dietary B12 Deficiency; Dietary Zinc Deficiency; Dietary Vitamin B12 Deficiency Anemia; Dietary Deficiency of Selenium and Vitamin E
• Intervention / Treatment: Dietary supplement: 30 day Daily consumption of 1 serving of beef; Dietary supplement: 30 day Daily consumption of 1 serving of the vegatable protein source

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: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven E Riechman, PhD; Phone Number: 9798623213; Email: sriechman@tamu.edu
• Study Contact Backup: Name: Susanne Talcott, PhD; Email: smtalcott@tamu.edu

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77845
      • Recruiting
      • Texas A&M University
      • Contact: Susanne Talcott, PhD; Email: smtalcott@tamu.edu
      • Contact: Steve Riechman, PhD; Phone Number: 979-862-3213; Email: sriechman@tamu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Markers of anemia	blood levels of B12, iron, CBCs, ferritin, hepcidin	Day 1 and Day 30 of the intervention

Collaborators and Investigators

• Sponsor: Texas A&M University
• Investigators: Principal Investigator: Steve Riechman, PhD, Texas A&M University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Vitamin B Deficiency; Anemia; Malnutrition; Vitamin B 12 Deficiency
• Other Study ID 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