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

Primary Purpose

Cognitive Change, Nutrient Deficiency, Nutritional Anemia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
30 day Daily consumption of 1 serving of beef
30 day Daily consumption of 1 serving of the vegatable protein source
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Change

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Texas A&M UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

30 day Beef consumption

30 day Veggie Patty consumption

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Blood Markers of anemia
blood levels of B12, iron, CBCs, ferritin, hepcidin

Full Information

First Posted
June 6, 2020
Last Updated
June 9, 2020
Sponsor
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT04427852
Brief Title
Nutrition, Vision, and Cognition in Sport Study: Beef
Acronym
IONSport:Beef
Official Title
Nutrition, Vision, and Cognition in Sport Study: Beef
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomized to either one serving of beef or a macronutrient equivalent "veggie patty" per day for 30 days.
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
30 day Beef consumption
Arm Type
Experimental
Arm Description
One serving of beef is consumed each day for 30 days.
Arm Title
30 day Veggie Patty consumption
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
30 day Daily consumption of 1 serving of beef
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
30 day Daily consumption of 1 serving of the vegatable protein source
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean NeuroTracker Speed Threshold over 300 trials
Description
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.
Time Frame
15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Title
Maximal NeuroTracker Speed Threshold over 300 trials
Description
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.
Time Frame
15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Title
Change in NeuroTracker Speed Threshold over 300 trials
Description
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.
Time Frame
15 sessions (300 trials) over 10 days at the end of the nutritional intervention
Secondary Outcome Measure Information:
Title
Blood Markers of anemia
Description
blood levels of B12, iron, CBCs, ferritin, hepcidin
Time Frame
Day 1 and Day 30 of the intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Biological female, normally menstruating
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-40 year old female Eumenorrheic Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven E Riechman, PhD
Phone
9798623213
Email
sriechman@tamu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Talcott, PhD
Email
smtalcott@tamu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Riechman, PhD
Organizational Affiliation
Texas A&M University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A&M University
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Riechman, PhD
Phone
979-862-3213
Email
sriechman@tamu.edu
First Name & Middle Initial & Last Name & Degree
Susanne Talcott, PhD
Email
smtalcott@tamu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will not share

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Nutrition, Vision, and Cognition in Sport Study: Beef

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