Clinical trial NCT06690892: Investigating the Effects of Beef Consumption on Cognitive and Brain Health
Official title: Understanding the Cognitive and Brain Health Effects of Increasing Beef Consumption in Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dietary Intervention
Dietary Proteins
Dietary Assessment
Cognitive Ability, General
Keywords: beef consumption
beef dietary intervention
brain health
cognitive health
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: The Beef Checkoff
First posted: 2024-11-15
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to evaluate the effects of beef consumption on cognitive and brain health in healthy young 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.

All participants will take part in a 12-week dietary intervention study. Throughout the intervention, participants will receive 5 portions of ready-to-eat beef in frozen packages each week. Each serving of ready-to-eat beef for the experimental group will weigh 5-ounces, while each serving of ready-to-eat beef for the comparison group will weigh 1-ounce. Study compliance will be evaluated through weekly surveys about beef consumption.

In addition to completing the dietary intervention, 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


Eligibility criteria: 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 during the 2024 school year
* Score between 49 and 64 out of 100 on the Healthy Eating Index
* Consume less than or equal to 1 ounce of beef per day on average prior to participating in the study
* 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
* Low beef consumers, and be willing to adhere to the assigned ready-to-eat beef intervention regimen during the study
* 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

Primary outcomes:
measure: WAIS-V
timeFrame: 12 Weeks
measure: Trail Making Test
timeFrame: 12 Weeks
measure: NIH Toolbox (Dimensional Change Card Sort)
timeFrame: 12 Weeks
measure: NIH Toolbox (Flanker)
timeFrame: 12 Weeks
measure: NIH Toolbox (List Sorting Working Memory Test)
timeFrame: 12 Weeks
measure: Adult Decision-Making Competence test
timeFrame: 12 Weeks
measure: Cognitive Reflection Test
timeFrame: 12 Weeks
measure: Attentional Network Task
timeFrame: 12 Weeks
measure: UCLA Loneliness Scale
timeFrame: 12 Weeks
measure: Short Form-36 Health Survey
timeFrame: 12 Weeks
measure: Psychological Wellbeing Scale
timeFrame: 12 Weeks
measure: Decision Outcome Inventory
timeFrame: 12 Weeks
measure: The Mindset Survey
timeFrame: 12 Weeks
measure: Need for Cognition Scale
timeFrame: 12 Weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 12 Weeks
measure: Ohio State Traumatic Brain Injury Identification
timeFrame: 12 Weeks
measure: Symptom Checklist 90-Revised
timeFrame: 12 Weeks
measure: Grit
timeFrame: 12 Weeks
measure: Brief Dispositional Resilience Scale
timeFrame: 12 Weeks
measure: Valence Bias Task
timeFrame: 12 Weeks
Secondary outcomes:
measure: Structural magnetic resonance imaging
timeFrame: 12 Weeks
measure: Susceptibility weighted imaging
timeFrame: 12 Weeks
measure: Diffusion tensor Imaging
timeFrame: 12 Weeks
measure: Magnetic resonance elastography
timeFrame: 12 Weeks
measure: Resting-state functional imaging
timeFrame: 12 Weeks
measure: Task-based functional imaging
timeFrame: 12 Weeks
measure: Naturalistic viewing functional imaging
timeFrame: 12 Weeks
Other outcomes:
measure: Height
timeFrame: 12 Weeks
measure: Weight
timeFrame: 12 Weeks
measure: Body Mass Index
timeFrame: 12 Weeks
measure: Heart Rate
timeFrame: 12 Weeks
measure: Heart Rate Variability
timeFrame: 12 Weeks
measure: Systolic Blood Pressure
timeFrame: 12 Weeks
measure: Diastolic Blood Pressure
timeFrame: 12 Weeks
measure: Body Composition
timeFrame: 12 Weeks
measure: Grip Strength
timeFrame: 12 Weeks
measure: Apolipoprotein A
timeFrame: 12 Weeks
measure: C-Reactive Protein
timeFrame: 12 Weeks
measure: Serum Amyloid P-Component
timeFrame: 12 Weeks
measure: Thyroxine-Binding Globulin
timeFrame: 12 Weeks
measure: von Willebrand Factor
timeFrame: 12 Weeks
measure: Beta 2 microglobulin
timeFrame: 12 Weeks
measure: Ferritin
timeFrame: 12 Weeks
measure: Adiponectin
timeFrame: 12 Weeks
measure: Myoglobin
timeFrame: 12 Weeks
measure: Plasminogen Activator Inhibitor 1
timeFrame: 12 Weeks
measure: alpha-2-macroglobulin
timeFrame: 12 Weeks
measure: T-cell-specific protein RANTES
timeFrame: 12 Weeks
measure: Tissue inhibitor of Metalloproteinases 1
timeFrame: 12 Weeks
measure: tumor necrosis factor receptor 2
timeFrame: 12 Weeks
measure: vascular cell adhesion molecule-1
timeFrame: 12 Weeks
measure: EN-RAGE Inflammatory Biomarker
timeFrame: 12 Weeks
measure: Pulmonary and Activation-Regulated chemokine
timeFrame: 12 Weeks
measure: Brain-Derived Neurotrophic Factor
timeFrame: 12 Weeks
measure: Interleukin-1 receptor antagonist
timeFrame: 12 Weeks
measure: Interleukin-1 alpha
timeFrame: 12 Weeks
measure: Interleukin-1 beta
timeFrame: 12 Weeks
measure: Interleukin-12 subunit p40
timeFrame: 12 Weeks
measure: Interleukin-12 subunit p70
timeFrame: 12 Weeks
measure: Interleukin-17
timeFrame: 12 Weeks
measure: Vascular Endothelial Growth Factor
timeFrame: 12 Weeks
measure: Intercellular Adhesion Molecule 1
timeFrame: 12 Weeks
measure: eotaxin-1
timeFrame: 12 Weeks
measure: factor VII
timeFrame: 12 Weeks
measure: matrix metalloproteinase-3
timeFrame: 12 Weeks
measure: matrix metalloproteinase-9
timeFrame: 12 Weeks
measure: stem cell factor
timeFrame: 12 Weeks
measure: Methylmalonic acid
timeFrame: 12 Weeks
measure: Choline
timeFrame: 12 Weeks
measure: Riboflavin
timeFrame: 12 Weeks
measure: Vitamin B6
timeFrame: 12 Weeks
measure: Niacin (Nicotinic acid)
timeFrame: 12 Weeks
measure: Vitamin B12
timeFrame: 12 Weeks
measure: Stearic acid
timeFrame: 12 Weeks
measure: oleic acid
timeFrame: 12 Weeks
measure: linoleic acid
timeFrame: 12 Weeks
measure: alpha-linolenic acid
timeFrame: 12 Weeks
measure: conjugated linoleic acid
timeFrame: 12 Weeks
measure: Arachidonic acid
timeFrame: 12 Weeks
measure: eicosapentaenoic acid
timeFrame: 12 Weeks
measure: docosanpetaenoic acid
timeFrame: 12 Weeks
measure: docosahexaenoic acid
timeFrame: 12 Weeks
measure: Glucose
timeFrame: 12 Weeks
measure: Triglycerides
timeFrame: 12 Weeks
measure: Low-density Lipoprotein
timeFrame: 12 Weeks
measure: High-density Lipoprotein
timeFrame: 12 Weeks
measure: Iron
timeFrame: 12 Weeks
measure: Zinc
timeFrame: 12 Weeks
measure: Selenium
timeFrame: 12 Weeks
measure: Phosphate
timeFrame: 12 Weeks
measure: Transferrin
timeFrame: 12 Weeks
measure: Blood Urea Nitrogen
timeFrame: 12 Weeks
measure: Insulin
timeFrame: 12 Weeks
measure: Interleukin 6
timeFrame: 12 Weeks
measure: Tumor Necrosis Factor-alpha
timeFrame: 12 Weeks
measure: Interleukin 2
timeFrame: 12 Weeks
measure: Interleukin 4
timeFrame: 12 Weeks
measure: Interleukin 8
timeFrame: 12 Weeks
measure: Interleukin 10
timeFrame: 12 Weeks
measure: Interferon Gamma
timeFrame: 12 Weeks
measure: Monocyte Chemotactic Protein 1 (CCL2)
timeFrame: 12 Weeks
measure: Granulocyte-Macrophage Colony-Stimulating Factor
timeFrame: 12 Weeks
measure: Macrophage Inflammatory Protein-1 alpha
timeFrame: 12 Weeks
measure: Interleukin 18
timeFrame: 12 Weeks
measure: Interleukin 3
timeFrame: 12 Weeks
measure: Interleukin 5
timeFrame: 12 Weeks
measure: Interleukin 7
timeFrame: 12 Weeks
measure: Tumor Necrosis Factor-beta
timeFrame: 12 Weeks
Locations:
city: Lincoln
country: United States
facility: University of Nebraska-Lincoln
state: Nebraska
Study officials:
affiliation: University of Nebraska Lincoln
name: Aron Barbey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.