- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06690892
Investigating the Effects of Beef Consumption on Cognitive and Brain Health
Understanding the Cognitive and Brain Health Effects of Increasing Beef Consumption in Young Adults
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
Study Overview
Status
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 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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aron Barbey, PhD
- Phone Number: 402-472-0168
- Email: abarbey2@unl.edu
Study Contact Backup
- Name: Douglas Schultz, PhD
- Phone Number: 402-472-1843
- Email: dschultz14@unl.edu
Study Locations
-
-
Nebraska
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Lincoln, Nebraska, United States, 68588
- Recruiting
- University of Nebraska-Lincoln
-
Principal Investigator:
- Aron Barbey, PhD
-
Contact:
- Douglas H Schultz, PhD
- Phone Number: 320-444-2948
- Email: dschultz14@unl.edu
-
Contact:
- Aron Barbey, PhD
- Phone Number: 402-472-1843
- Email: abarbey2@unl.edu
-
Principal Investigator:
- Douglas H Schultz, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
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.
|
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.
|
|
Placebo Comparator: Control Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WAIS-V
Time Frame: Baseline and after 12 weeks
|
Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities
|
Baseline and after 12 weeks
|
|
NIH Toolbox (Dimensional Change Card Sort)
Time Frame: Baseline and after 12 weeks
|
Test for executive function and cognitive flexibility
|
Baseline and after 12 weeks
|
|
NIH Toolbox (Flanker)
Time Frame: Baseline and after 12 weeks
|
test for executive functions: attention and inhibitory control
|
Baseline and after 12 weeks
|
|
NIH Toolbox (List Sorting Working Memory Test)
Time Frame: Baseline and after 12 weeks
|
Test for working memory
|
Baseline and after 12 weeks
|
|
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
|
Baseline and after 12 weeks
|
|
Short Form-36 Health Survey
Time Frame: Baseline and after 12 weeks
|
self-report measure of health status and quality of life
|
Baseline and after 12 weeks
|
|
Decision Outcome Inventory
Time Frame: Baseline and after 12 weeks
|
an assessment of outcomes of real-life decisions
|
Baseline and after 12 weeks
|
|
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
|
Baseline and after 12 weeks
|
|
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
|
Baseline and after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain Imaging
Time Frame: Baseline and after 12 weeks
|
|
Baseline and after 12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: Baseline and after 12 weeks
|
measured in feet and inches
|
Baseline and after 12 weeks
|
|
Weight
Time Frame: Baseline and after 12 weeks
|
measured in pounds (lbs)
|
Baseline and after 12 weeks
|
|
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
|
Baseline and after 12 weeks
|
|
Systolic and Diastolic Blood Pressure
Time Frame: Baseline and after 12 weeks
|
Measured in mmHg
|
Baseline and after 12 weeks
|
|
Body Composition
Time Frame: Baseline and after 12 weeks
|
Body composition will be measured in body fat%
|
Baseline and after 12 weeks
|
|
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.
|
Baseline and after 12 weeks
|
|
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
|
Baseline and after 12 weeks
|
|
Heart Rate
Time Frame: Baseline and after 12 weeks
|
Heart rate will be reported as beats per minute.
|
Baseline and after 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aron Barbey, PhD, University of Nebraska Lincoln
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23404
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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