Nutrition, Vision, and Cognition in Sport Study: Beef

Cognitive Change Clinical Trial

— IONSport:Beef  

Official title:

Nutrition, Vision, and Cognition in Sport Study: Beef

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427852
• Other study ID #: M1803347
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2020
• Source: Texas A&M University
• Contact: Steven E Riechman, PhD
• Phone: 9798623213
• Email: sriechman[@]tamu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Cognitive Change
• Diet, Healthy
• Diet; Deficiency
• Dietary B12 Deficiency
• Dietary Deficiency
• Dietary Deficiency of Selenium and Vitamin E
• Dietary Vitamin B12 Deficiency Anemia
• Dietary Zinc Deficiency
• Malnutrition
• Nutrient Deficiency
• Nutritional Anemia
• Visual Spatial Processing
• Vitamin B 12 Deficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Texas A&M University	College Station	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Blood Markers of anemia	blood levels of B12, iron, CBCs, ferritin, hepcidin	Day 1 and Day 30 of the intervention