Cognitive Ability, General, Dietary Assessment, Dietary Intervention, Dietary Proteins
Conditions
Keywords
beef consumption, beef dietary intervention, brain health, cognitive health
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
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
Interventions
DIETARY_SUPPLEMENTReady-to-eat beef in frozen, 5-oz packages
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.
DIETARY_SUPPLEMENTReady-to-eat beef in frozen, 1-oz packages
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.
Sponsors
University of Nebraska Lincoln
National Cattlemen's Beef Association, a contractor to the Beef Checkoff
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WAIS-V | Baseline and after 12 weeks | Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities |
| 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 |
| NIH Toolbox (List Sorting Working Memory Test) | Baseline and after 12 weeks | Test for working memory |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Brain Imaging | 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 |
Countries
United States
Contacts
CONTACTDouglas Schultz, PhD
CONTACTAron Barbey, PhD
PRINCIPAL_INVESTIGATORAron Barbey, PhD
University of Nebraska Lincoln
Outcome results
None listed