Investigating the Effects of Beef Consumption on Cognitive and Brain Health

ConditionsDietary Intervention Dietary Proteins Dietary Assessment Cognitive Ability, General

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19-24

SponsorUniversity of Nebraska Lincoln

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: Experimental GroupExperimental treatment 1 intervention

Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

WAIS-V

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

Time frame

Baseline and after 12 weeks

NIH Toolbox (Dimensional Change Card Sort)

Test for executive function and cognitive flexibility

Time frame

Baseline and after 12 weeks

NIH Toolbox (Flanker)

test for executive functions: attention and inhibitory control

Time frame

Baseline and after 12 weeks

NIH Toolbox (List Sorting Working Memory Test)

Test for working memory

Time frame

Baseline and after 12 weeks

Secondary outcomes

Brain Imaging

* 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

Time frame

Baseline and after 12 weeks

Other outcomes

Height

measured in feet and inches

Time frame

Baseline and after 12 weeks

Weight

measured in pounds (lbs)

Time frame

Baseline and after 12 weeks

Body Mass Index

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

Time frame

Baseline and after 12 weeks

Heart Rate

Heart rate will be reported as beats per minute.

Time frame

Baseline and after 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska Lincoln

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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