Understanding the Cognitive and Brain Health Effects of Increasing Beef Consumption in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- WAIS-V
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 24 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Group
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, and consume 5 portions per week. Each portion of beef provided to this group will weigh 5 ounces.
干预措施: Ready-to-eat beef in frozen, 5-oz packages (Dietary Supplement)
Control Group
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, and consume 5 portions per week. Each portion of beef provided to this group will weigh 1 ounce.
干预措施: Ready-to-eat beef in frozen, 1-oz packages (Dietary Supplement)
结局指标
主要结局
WAIS-V
时间窗: Baseline and after 12 weeks
Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities
NIH Toolbox (Dimensional Change Card Sort)
时间窗: Baseline and after 12 weeks
Test for executive function and cognitive flexibility
NIH Toolbox (Flanker)
时间窗: Baseline and after 12 weeks
test for executive functions: attention and inhibitory control
NIH Toolbox (List Sorting Working Memory Test)
时间窗: Baseline and after 12 weeks
Test for working memory
Cognitive Reflection Test
时间窗: 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
时间窗: Baseline and after 12 weeks
self-report measure of health status and quality of life
Decision Outcome Inventory
时间窗: Baseline and after 12 weeks
an assessment of outcomes of real-life decisions
Pittsburgh Sleep Quality Index
时间窗: 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
时间窗: 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
次要结局
- Brain Imaging(Baseline and after 12 weeks)
- Brain Imaging(Baseline and after 12 weeks)
