Investigating the Effects of Beef Consumption on Cognitive and Brain Health

University of Nebraska

Status: Enrolling

Conditions: Dietary Intervention; Dietary Assessment; Cognitive Ability, General; Dietary Proteins

Treatments: Dietary Supplement: Ready-to-eat beef in frozen, 1-oz packages; Dietary Supplement: Ready-to-eat beef in frozen, 5-oz packages

Study type: Interventional

Funder types: Other

Identifiers

NCT06690892

23404

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 19 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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. Each portion of beef provided to this group will weigh 5 ounces.

Treatment:

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

Control Group

Placebo Comparator group

Description:

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. Each portion of beef provided to this group will weigh 1 ounces.

Treatment:

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