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NCT Number: NCT06690892

Investigating the Effects of Beef Consumption on Cognitive and Brain Health

The goal of this clinical trial is to learn if eating more beef will lead to better cognition and a healthier brain in younger adults. The main questions it aims to answer are:

* Does eating more beef lead to higher scores on cognitive tests and better quality of life? * Does eating more beef lead to better brain function?

Researchers will compare participants in the experimental group (participants who will eat 25 ounces of beef every week during the dietary intervention) to control participants (participants who will eat 5 ounces of beef every week during the dietary intervention).

Participants will:

* Be instructed to prepare and consume ready-to-eat beef meals along with their regular diet and not eat any more beef other than what they are given * Visit the study facilities once every week to pick up ready-to-eat beef meals; and complete a brief survey every week to track their consumption of the provided beef meals, and a dietary survey every 4 weeks * Visit the study facilities before and after the 12-week of intervention period for researchers to study them

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Key information

Conditions

Dietary Intervention Cognitive Ability, General Dietary Assessment Dietary Proteins

Age range

19 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588, United States

Location status: Recruiting

Location contact

Aron Barbey, PhD

CONTACT

[email protected]

402-472-1843

Aron Barbey, PhD

PRINCIPAL_INVESTIGATOR

Douglas H Schultz, PhD

CONTACT

[email protected]

320-444-2948

Douglas H Schultz, PhD

PRINCIPAL_INVESTIGATOR

About this study

The goal of this study is to evaluate the effects of beef consumption on cognitive and brain health in healthy younger adults. Specifically, we seek to evaluate the effects of beef consumption on measures of executive function, memory, psychological well-being, and sleep quality. Additionally, we will explore the effects of increased beef consumption on measures of brain health derived from structural and functional brain imaging.

The study will consist of two groups of participants: experimental and control. Participants from both groups will take part in a 12-week dietary intervention. Throughout the intervention, participants in the experimental group will receive 5 portions of ready-to-eat lean beef in frozen packages every week; and consume 5 portions per week. Each serving of ready-to-eat beef for the experimental group will weigh 5-ounces. Participants in the control group will also receive 5 portions of ready-to-eat lean beef in frozen packages every week; and consume 5 portions per week. Each serving of ready-to-eat beef for the control group will weigh 1-ounce. Study compliance will be evaluated through weekly surveys about beef consumption.

In addition, all participants will complete pre- and post-intervention assessments:

  • MRI scan, including structural and functional brain imaging
  • a comprehensive questionnaire battery evaluating cognitive and psychological measures
  • neuropsychological tasks
  • a blood draw

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  • Males and females; Age 19-24
  • Willingness to adhere to the ready-to-eat beef intervention regimen
  • Lives within 75 miles of Lincoln, NE
  • BMI between 18.5 and 39.9
  • Not pregnant or nursing
  • No history of cognitive or metabolic diseases indicated by diagnosis, including neurodegenerative disease, stroke, Type 1 and 2 diabetes, metabolic syndrome, cardiovascular disease, liver disease, kidney disease, and cancer
  • No history of eating or anxiety disorders
  • Willing to discontinue dietary supplement use throughout the duration of the study, if they are consuming supplement at the time of the registration
  • No known contraindication to MRI scans as determined by the MRI screening survey questions

Exclusion criteria

  • Current use of medications that may affect their responses to dietary intervention, such as amphetamines, antidepressants, anti-diabetic medications, laxatives, antibiotics, statins and diuretics.
  • Known intolerance or allergy to beef
  • Current use of nicotine products, including vaping
  • Previous use of nicotine products, including vaping, within the recent 6 months at the time of pre-screening

Treatment and study plan

Ready-to-eat beef in frozen, 5-oz packages

Dietary Supplement

The dietary intervention lasts 12 weeks for each individual. Participants in the experimental group will receive this intervention. Each participant will acquire 5 portions of ready-to eat beef in frozen packages per week, and consume 5 portions per week (1 portion of sirloin cap steak strips, 1 portion of shredded chuck roast, 1 portion of petite shoulder medallions, and 2 portions of ground beef crumbles); each portion of ready-to-eat beef in this intervention will weigh 5 ounces.

Ready-to-eat beef in frozen, 1-oz packages

Dietary Supplement

The dietary intervention lasts 12 weeks for each individual. Participants in the control group will receive this intervention. Each participant will acquire 5 portions of ready-to eat beef in frozen packages per week, and consume 5 portions per week (1 portion of sirloin cap steak strips, 1 portion of shredded chuck roast, 1 portion of petite shoulder medallions, and 2 portions of ground beef crumbles); each portion of ready-to-eat beef in this intervention will weigh 1 ounce.

Primary outcomes

  1. WAIS-V

    Time frame: Baseline and after 12 weeks

    Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities

  2. NIH Toolbox (Dimensional Change Card Sort)

    Time frame: Baseline and after 12 weeks

    Test for executive function and cognitive flexibility

  3. NIH Toolbox (Flanker)

    Time frame: Baseline and after 12 weeks

    test for executive functions: attention and inhibitory control

  4. NIH Toolbox (List Sorting Working Memory Test)

    Time frame: Baseline and after 12 weeks

    Test for working memory

  5. Cognitive Reflection Test

    Time frame: Baseline and after 12 weeks

    Test to measure the ability to suppress an intuitive wrong answer in favor of a more reflective correct answer

  6. Short Form-36 Health Survey

    Time frame: Baseline and after 12 weeks

    self-report measure of health status and quality of life

  7. Decision Outcome Inventory

    Time frame: Baseline and after 12 weeks

    an assessment of outcomes of real-life decisions

  8. Pittsburgh Sleep Quality Index

    Time frame: Baseline and after 12 weeks

    Self-report assessment of sleep quality over the past month. The survey includes measures related to Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disturbances, Use of Sleep Medications, Daytime Fatigue, and Sleep Quality

  9. Symptom Checklist 90-Revised

    Time frame: Baseline and after 12 weeks

    self-report assessment of psychological symptoms related to the domains of somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism

Secondary outcomes

  1. Brain Imaging

    Time frame: Baseline and after 12 weeks

    • T1- weighted imaging to visualize the structure of the brain
    • Functional MRI of the whole brain to examine changes in brain activity and functional topology
    • Diffusion tensor imaging to map the white matter structures in the brain

Other outcomes

  1. Height

    Time frame: Baseline and after 12 weeks

    measured in feet and inches

  2. Weight

    Time frame: Baseline and after 12 weeks

    measured in pounds (lbs)

  3. Body Mass Index

    Time frame: Baseline and after 12 weeks

    Calculated by body mass divided by the square of the body height, unit in kg/m^2

  4. Heart Rate

    Time frame: Baseline and after 12 weeks

    Heart rate will be reported as beats per minute.

  5. Systolic and Diastolic Blood Pressure

    Time frame: Baseline and after 12 weeks

    Measured in mmHg

  6. Body Composition

    Time frame: Baseline and after 12 weeks

    Body composition will be measured in body fat%

  7. Grip Strength

    Time frame: Baseline and after 12 weeks

    Participants will squeeze a hydraulic device three times with their right hand. Grip strength will be obtained by averaging the three measurements, which will be measured in kilograms.

  8. Blood-based biomarkers associated with consumption of beef

    Time frame: Baseline and after 12 weeks

    Biomarkers under evaluation include inflammatory biomarkers and nutrient biomarkers in blood from participants

Study contacts

Contact information is provided by the study sponsor or research team.

Aron Barbey, PhD

CONTACT

[email protected]

402-472-0168

Douglas Schultz, PhD

CONTACT

[email protected]

402-472-1843

Sponsors and collaborators

Lead sponsor

University of Nebraska Lincoln

Other

Collaborators

  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Registry information

Official study title

Understanding the Cognitive and Brain Health Effects of Increasing Beef Consumption in Young Adults

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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