Nutrition, Vision, and Cognition in Sport Study: Beef

Not Applicable

• Conditions: Dietary Vitamin B12 Deficiency Anemia; Cognitive Change; Dietary B12 Deficiency; Visual Spatial Processing; Diet; Deficiency; Dietary Zinc Deficiency; Nutrient Deficiency; Nutritional Anemia; Diet, Healthy; Dietary Deficiency
• Interventions: 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

• Registration Number: NCT04427852
• Lead Sponsor: Texas A&M University

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.

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 Timeline

• Study Start: 2020-01-20
• Status Verified: 2020-06
• Study First Submitted: 2020-06-06
• Study First Submitted QC: 2020-06-09
• Last Update Submitted: 2020-06-09
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 day Beef consumption	30 day Daily consumption of 1 serving of beef	One serving of beef is consumed each day for 30 days.
30 day Veggie Patty consumption	30 day Daily consumption of 1 serving of the vegatable protein source	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.

Primary Outcome Measures

Name	Time	Method
Mean NeuroTracker Speed Threshold over 300 trials	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Blood Markers of anemia	Day 1 and Day 30 of the intervention	blood levels of B12, iron, CBCs, ferritin, hepcidin

Trial Locations

Locations (1)

Texas A&M University; 🇺🇸 College Station, Texas, United States