Investigating the Effects of Beef Consumption on Cognitive and Brain Health

Not Applicable

Recruiting

• Conditions: Dietary Intervention; Dietary Proteins; Dietary Assessment; Cognitive Ability, General

• Registration Number: NCT06690892
• Lead Sponsor: University of Nebraska Lincoln

Brief Summary

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 two weeks to pick up ready-to-eat beef meals; or 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

Detailed Description

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 10 portions of ready-to-eat lean beef in frozen packages every two weeks; 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 10 portions of ready-to-eat lean beef in frozen packages every two weeks; 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

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-11-13
• Study First Posted: 2024-11-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-26
• Study Start: 2025-08-01
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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
• Enrolled at University of Nebraska-Lincoln
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
WAIS-V	Baseline and after 12 weeks	Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities
NIH Toolbox (List Sorting Working Memory Test)	Baseline and after 12 weeks	Test for working memory
NIH Toolbox (Dimensional Change Card Sort)	Baseline and after 12 weeks	Test for executive function and cognitive flexibility
NIH Toolbox (Flanker)	Baseline and after 12 weeks	test for executive functions: attention and inhibitory control
Cognitive Reflection Test	Baseline and after 12 weeks	Test to measure the ability to suppress an intuitive wrong answer in favor of a more reflective correct answer
Short Form-36 Health Survey	Baseline and after 12 weeks	self-report measure of health status and quality of life
Decision Outcome Inventory	Baseline and after 12 weeks	an assessment of outcomes of real-life decisions
Pittsburgh Sleep Quality Index	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
Symptom Checklist 90-Revised	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 Outcome Measures

Name	Time	Method
Brain Imaging	Baseline and after 12 weeks	* T1- and T2-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; * Magnetic resonance elastography to examine the elasticity of brain tissues; * Susceptibility weighted imaging to examine cerebrovascular health; * Magnetic Resonance Spectroscopy to examine concentrations of metabolites in the brain

Trial Locations

Locations (1)

University of Nebraska-Lincoln; 🇺🇸 Lincoln, Nebraska, United States