<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04427852</url>
  </required_header>
  <id_info>
    <org_study_id>M1803347</org_study_id>
    <nct_id>NCT04427852</nct_id>
  </id_info>
  <brief_title>Nutrition, Vision, and Cognition in Sport Study: Beef</brief_title>
  <acronym>IONSport:Beef</acronym>
  <official_title>Nutrition, Vision, and Cognition in Sport Study: Beef</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas A&amp;M University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a 30 day beef intervention can improve peak&#xD;
      cognitive performance in young, normally menstruating adult women. The control group will&#xD;
      consume a daily portion of macronutrient equivalent vegetable source of protein.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the Nutrition, Vision, and Cognition in Health Sport: Beef (IONSport-Beef)&#xD;
      study is to conduct a randomized controlled trial to evaluate beef as a nutritional&#xD;
      intervention to optimize visual cognitive training performance in generally healthy, normally&#xD;
      menstruating women. Female subjects of reproductive age (18-40) will be randomly placed in&#xD;
      one of two dietary treatment groups: one serving of beef per day for 30 days or a non-meat&#xD;
      protein replacement control. Cognitive performance will be measured in 15 training sessions&#xD;
      over 10 days using the sophisticated NeuroTracker™ CORE (NT) 3-Dimensional (3D) software&#xD;
      program. It is hypothesized that women consuming 1 serving of beef per day for 30 days will&#xD;
      have the highest plasma levels of the beef rich nutrients and demonstrate the highest visual&#xD;
      cognitive performance and improvement as compared to the no beef control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 20, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Study participants will be randomized to either one serving of beef or a macronutrient equivalent &quot;veggie patty&quot; per day for 30 days.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>note on masking: The title of the study presented to participants is &quot;IONsport: Women and Protein&quot; 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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean NeuroTracker Speed Threshold over 300 trials</measure>
    <time_frame>15 sessions (300 trials) over 10 days at the end of the nutritional intervention</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximal NeuroTracker Speed Threshold over 300 trials</measure>
    <time_frame>15 sessions (300 trials) over 10 days at the end of the nutritional intervention</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in NeuroTracker Speed Threshold over 300 trials</measure>
    <time_frame>15 sessions (300 trials) over 10 days at the end of the nutritional intervention</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Markers of anemia</measure>
    <time_frame>Day 1 and Day 30 of the intervention</time_frame>
    <description>blood levels of B12, iron, CBCs, ferritin, hepcidin</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cognitive Change</condition>
  <condition>Nutrient Deficiency</condition>
  <condition>Nutritional Anemia</condition>
  <condition>Visual Spatial Processing</condition>
  <condition>Diet, Healthy</condition>
  <condition>Diet; Deficiency</condition>
  <condition>Dietary Deficiency</condition>
  <condition>Dietary B12 Deficiency</condition>
  <condition>Dietary Zinc Deficiency</condition>
  <condition>Dietary Vitamin B12 Deficiency Anemia</condition>
  <condition>Dietary Deficiency of Selenium and Vitamin E</condition>
  <arm_group>
    <arm_group_label>30 day Beef consumption</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One serving of beef is consumed each day for 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 day Veggie Patty consumption</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>30 day Daily consumption of 1 serving of beef</intervention_name>
    <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.</description>
    <arm_group_label>30 day Beef consumption</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>30 day Daily consumption of 1 serving of the vegatable protein source</intervention_name>
    <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.</description>
    <arm_group_label>30 day Veggie Patty consumption</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-40 year old female&#xD;
&#xD;
          2. Eumenorrheic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Neuroactive medications such as Ritalin, Adderall, antidepressants etc&#xD;
&#xD;
          2. Dietary supplements&#xD;
&#xD;
          3. Iron intake above 15mg/day&#xD;
&#xD;
          4. Protein intake above 1.5 g/kg/day&#xD;
&#xD;
          5. More than 1 mild concussion lifetime or 1 mild concussion within the last 12 months&#xD;
&#xD;
          6. History of affective disorder&#xD;
&#xD;
          7. Visual impairments uncorrected by glasses&#xD;
&#xD;
          8. Amenorrhea or dysmenorrhea&#xD;
&#xD;
          9. Currently being treated for anemia&#xD;
&#xD;
         10. &gt;3 servings of beef per week&#xD;
&#xD;
         11. &lt;20 BMI or BMI &gt;35&#xD;
&#xD;
         12. Consume &gt;100mg caffeine/day (&gt;1 cup of coffee or soda)&#xD;
&#xD;
         13. &lt;1 hour/week physical activity, &gt;4 hours/week vigorous activity&#xD;
&#xD;
         14. Depression score &gt;18 (Beck Depression Inventory)&#xD;
&#xD;
         15. &lt;20 Kcal/kg/day&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Biological female, normally menstruating</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steve Riechman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas A&amp;M University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Steven E Riechman, PhD</last_name>
    <phone>9798623213</phone>
    <email>sriechman@tamu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Susanne Talcott, PhD</last_name>
    <email>smtalcott@tamu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Texas A&amp;M University</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Steve Riechman, PhD</last_name>
      <phone>979-862-3213</phone>
      <email>sriechman@tamu.edu</email>
    </contact>
    <contact_backup>
      <last_name>Susanne Talcott, PhD</last_name>
      <email>smtalcott@tamu.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas A&amp;M University</investigator_affiliation>
    <investigator_full_name>Steven E.Riechman, PhD, MPH</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Vitamin B 12 Deficiency</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Will not share</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427852
org study id: M1803347
nct id: NCT04427852
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
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.
measure: Mean NeuroTracker Speed Threshold over 300 trials
time frame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
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.
measure: Maximal NeuroTracker Speed Threshold over 300 trials
time frame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
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.
measure: Change in NeuroTracker Speed Threshold over 300 trials
time frame: 15 sessions (300 trials) over 10 days at the end of the nutritional intervention
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.
measure: Blood Markers of anemia
time frame: Day 1 and Day 30 of the intervention
description: blood levels of B12, iron, CBCs, ferritin, hepcidin
arm group label: 30 day Beef consumption
arm group type: Experimental
description: One serving of beef is consumed each day for 30 days.
arm group label: 30 day Veggie Patty consumption
arm group type: Placebo Comparator
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: 30 day Daily consumption of 1 serving of beef
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.
arm group label: 30 day Beef consumption
intervention type: Dietary Supplement
intervention name: 30 day Daily consumption of 1 serving of the vegatable protein source
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.
arm group label: 30 day Veggie Patty consumption
criteria: 
gender: Female
gender based: Yes
gender description: Biological female, normally menstruating
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steve Riechman, PhD
role: Principal Investigator
affiliation: Texas A&M University
last name: Steven E Riechman, PhD
phone: 9798623213
email: sriechman@tamu.edu
last name: Susanne Talcott, PhD
email: smtalcott@tamu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas A&M University
investigator full name: Steven E.Riechman, PhD, MPH
investigator title: Associate Professor
mesh term: Anemia
mesh term: Vitamin B 12 Deficiency
mesh term: Malnutrition
sharing ipd: No
ipd description: Will not share