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

Study type: Interventional

Funder types: Other

Identifiers

NCT06690892

23404

Details and patient eligibility

About

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 two weeks to pick up ready-to-eat beef meals; or 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

Full 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 10 portions of ready-to-eat lean beef in frozen packages every two weeks; 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 10 portions of ready-to-eat lean beef in frozen packages every two weeks; 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

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
• 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

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 10 portions of ready-to-eat beef in frozen packages once every two weeks, and consume 5 portions 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 10 portions of ready-to-eat beef in frozen packages once every two weeks, and consume 5 portions per week. Each portion of beef provided to this group will weigh 1 ounce.

Treatment:

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