NCT06690892

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 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

October 28, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

October 28, 2024

Last Update Submit

February 6, 2026

Conditions

Keywords

beef consumptionbeef dietary interventionbrain healthcognitive health

Outcome Measures

Primary Outcomes (9)

  • WAIS-V

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

    Baseline and after 12 weeks

  • NIH Toolbox (Dimensional Change Card Sort)

    Test for executive function and cognitive flexibility

    Baseline and after 12 weeks

  • NIH Toolbox (Flanker)

    test for executive functions: attention and inhibitory control

    Baseline and after 12 weeks

  • NIH Toolbox (List Sorting Working Memory Test)

    Test for working memory

    Baseline and after 12 weeks

  • Cognitive Reflection Test

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

    Baseline and after 12 weeks

  • Short Form-36 Health Survey

    self-report measure of health status and quality of life

    Baseline and after 12 weeks

  • Decision Outcome Inventory

    an assessment of outcomes of real-life decisions

    Baseline and after 12 weeks

  • Pittsburgh Sleep Quality Index

    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

    Baseline and after 12 weeks

  • Symptom Checklist 90-Revised

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

    Baseline and after 12 weeks

Secondary Outcomes (1)

  • Brain Imaging

    Baseline and after 12 weeks

Other Outcomes (8)

  • Height

    Baseline and after 12 weeks

  • Weight

    Baseline and after 12 weeks

  • Body Mass Index

    Baseline and after 12 weeks

  • +5 more other outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will participate in the 12-week beef dietary intervention study. Participants will be provided with 5 portions of ready-to-eat beef in frozen packages per week, and consume 5 portions per week. Each portion of beef provided to this group will weigh 5 ounces.

Dietary Supplement: Ready-to-eat beef in frozen, 5-oz packages

Control Group

PLACEBO COMPARATOR

The control group will participate in the 12-week beef dietary intervention. Participants will be provided with 5 portions of ready-to-eat beef in frozen packages per week, and consume 5 portions per week. Each portion of beef provided to this group will weigh 1 ounce.

Dietary Supplement: Ready-to-eat beef in frozen, 1-oz packages

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

Age19 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588, United States

RECRUITING

Related Publications (2)

  • Zhang H, Hardie L, Bawajeeh AO, Cade J. Meat Consumption, Cognitive Function and Disorders: A Systematic Review with Narrative Synthesis and Meta-Analysis. Nutrients. 2020 May 24;12(5):1528. doi: 10.3390/nu12051528.

    PMID: 32456281BACKGROUND
  • Hepsomali P, Groeger JA. Diet and general cognitive ability in the UK Biobank dataset. Sci Rep. 2021 Jun 3;11(1):11786. doi: 10.1038/s41598-021-91259-3.

    PMID: 34083695BACKGROUND

MeSH Terms

Interventions

Freezing

Intervention Hierarchy (Ancestors)

Phase TransitionPhysical PhenomenaCold TemperatureTemperatureThermodynamicsChemical Phenomena

Study Officials

  • Aron Barbey, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas Schultz, PhD

CONTACT

Aron Barbey, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2024

First Posted

November 15, 2024

Study Start

September 22, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Study findings will be submitted to peer-reviewed journals such as those that follow the ICMJE's recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. The data collected in this project may be shared through public-use files, repositories or other means outside of the approved research team as a requirement of publication. All data will be identified with subject IDs only when shared. Research records such as informed consent forms, MRI Safety Screening forms, research compliance records, masterlist linking names to subject IDs will not be shared.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
IPD and supporting information will be available beginning 1 year after the publication of results with no end date.
Access Criteria
Researchers who provide a methodologically sound proposal will be able to access the IPD and supporting information. Researchers are not restricted on the type of analyses, as long as they are methodologically sound. The statistical methods for those analyses must be approved before the researchers can gain access to the data. For data sharing, a proposal that describes planned analyses must be submitted to the study's contact personnel for review. A data sharing agreement must be signed between the institution of the requesting researchers and the institution of the study's principal investigator.

Locations