Clinical trial NCT04427852: Nutrition, Vision, and Cognition in Sport Study: Beef
Official title: Nutrition, Vision, and Cognition in Sport Study: Beef
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Change
Nutrient Deficiency
Nutritional Anemia
Visual Spatial Processing
Diet, Healthy
Diet; Deficiency
Dietary Deficiency
Dietary B12 Deficiency
Dietary Zinc Deficiency
Dietary Vitamin B12 Deficiency Anemia
Dietary Deficiency of Selenium and Vitamin E
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomized to either one serving of beef or a macronutrient equivalent "veggie patty" per day for 30 days.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean NeuroTracker Speed Threshold over 300 trials
timeFrame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
measure: Maximal NeuroTracker Speed Threshold over 300 trials
timeFrame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
measure: Change in NeuroTracker Speed Threshold over 300 trials
timeFrame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Secondary outcomes:
measure: Blood Markers of anemia
timeFrame: Day 1 and Day 30 of the intervention
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M University
state: Texas
Study officials:
affiliation: Texas A&M University
name: Steve Riechman, PhD
role: PRINCIPAL_INVESTIGATOR
References: