Investigating the Cognitive and Brain Health Benefits of Lean Pork Consumption
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Grit
研究概览
简要总结
The goal of this clinical trial is to learn if eating more lean pork will lead to better cognition and a healthier brain in older adults. The main questions it aims to answer are:
- Does eating more lean pork lead to higher scores on cognitive tests and better quality of life?
- Does eating more lean pork lead to slower brain aging and/or better brain function?
Researchers will compare participants in the experimental group (participants undergoing the dietary intervention) to control participants (participants that do not undergo the intervention).
Participants will:
- Be instructed to prepare and consume ready-to-eat pork meals along with their regular diet and not eat any more pork other than what they are given; or be instructed to consume their regular diet
- Visit the study facilities once every week to pick up ready-to-eat pork meals and complete dietary surveys; or complete dietary surveys every 4 weeks
- Visit the study facilities before and after the 16-week of intervention period for researchers to study them
详细描述
The goal of this study is to evaluate the effects of learn pork consumption on cognitive and brain health in healthy older adults. Specifically, we seek to evaluate the effects of lean pork consumption on measures of executive function, memory, psychological well-being, and sleep quality. Additionally, we will explore the effects of increased lean pork 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 in the experimental group will take part in a 16-week dietary intervention. Throughout the intervention, participants in the experimental group will receive 4 portions of ready-to-eat lean pork in frozen packages each week. Each serving of ready-to-eat lean pork for the experimental group will weigh 5-ounces. Participants in the control group will be asked to continue their regular diet, without receiving any frozen packages of ready-to-eat lean pork. Study compliance will be evaluated through weekly surveys about lean pork 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
- 65 Years 至 75 Years（Older 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 65-75
- •Willingness to adhere to the ready-to-eat lean pork intervention regimen or the control condition regimen (depending on group assignment)
- •Score between 51 and 80 out of 100 on the Healthy Eating Index
- •Consume less than or equal to 15 grams of lean pork per day on average prior to participating in the study
- •BMI between 18.5 and 39.9
- •Mini-Mental State Examination score 26 or greater
- •Vision scored greater than 20/50
- •No history of subjective cognitive impairment
- •No evidence of loss of instrumental activities of daily living
- •Minimal dependence in hygiene, bathing, and dressing
- •Low pork consumers
- •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 pork
- •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
- •Diagnosis of mild cognitive impairment
- •Diagnosis of any dementia, including, but not limited to, Alzheimer's Disease, Lewy body disease, vascular cognitive impairment and frontotemporal dementia
- •Diagnosis of psychiatric illness within the last 3 years
- •Stroke in previous 12 months
- •Cancer diagnosis within past 3 years, except prostate cancer or basal cell carcinoma
- •Current chemotherapy or radiation treatment
- •Planned move from study area
- •Scheduling conflicts that would preclude participation in study activities
- •Prior or ongoing involvement in cognitive training or dietary intervention studies
- •Contraindications for MRI
- •Dietary quality outside the average range (i.e., HEI score less than 51 or greater than 80)
- •Other inability to complete study activities
结局指标
主要结局
Grit
时间窗: Baseline and after 16 weeks
self-report measure of perseverance
WAIS-V
时间窗: Baseline and after 16 weeks
Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities
Trail Making Test
时间窗: Baseline and after 16 weeks
Delis-Kaplan Executive Function System test for sequencing and cognitive flexibility
NIH Toolbox (Dimensional Change Card Sort)
时间窗: Baseline and after 16 weeks
Test for executive function and cognitive flexibility
NIH Toolbox (Flanker)
时间窗: Baseline and after 16 weeks
test for executive functions: attention and inhibitory control
NIH Toolbox (List Sorting Working Memory Test)
时间窗: Baseline and after 16 weeks
Test for working memory
Adult Decision-Making Competence test
时间窗: Baseline and after 16 weeks
Assessment of how well adults make decisions. Subcategories include Resistance to Framing, Recognizing Social Norms, Under/Overconfidence, Applying Decision Rules, Consistency in Risk Perception, and Resistance to Sunk Costs
Cognitive Reflection Test
时间窗: Baseline and after 16 weeks
Test to measure the ability to suppress an intuitive wrong answer in favor of a more reflective correct answer
Attentional Network Task
时间窗: Baseline and after 16 weeks
Computerized task to measure the effects of visual and auditory cues on visual processing
UCLA Loneliness Scale
时间窗: Baseline and after 16 weeks
measure of subjective loneliness and social isolation
Short Form-36 Health Survey
时间窗: Baseline and after 16 weeks
self-report measure of health status and quality of life
Psychological Wellbeing Scale
时间窗: Baseline and after 16 weeks
the psychological wellbeing scale assesses six aspects of psychological wellbeing and happiness: Autonomy, Environmental Mastery, Personal Growth, Positive Relations with Others, Purpose in Life, Self-Acceptance
Decision Outcome Inventory
时间窗: Baseline and after 16 weeks
an assessment of outcomes of real-life decisions
The Mindset Survey
时间窗: Baseline and after 16 weeks
an assessment to determine whether an individual has a fixed mindset or a growth mindset
Need for Cognition Scale
时间窗: Baseline and after 16 weeks
assessment of an individual's tendency to engage in and enjoy thinking or mental exertion
Pittsburgh Sleep Quality Index
时间窗: Baseline and after 16 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
Consortium to Establish a Registry for Alzhiemer's Disease Word List Acquisition and Delayed Recall
时间窗: Baseline and after 16 weeks
A learning and delay memory recall task that is used to quickly assess an individual's mental capacity in memory.
Geriatric Depression Scale
时间窗: Baseline and after 16 weeks
Assessment of an older adult's status of mental health that screens for depression
Ohio State Traumatic Brain Injury Identification
时间窗: Baseline and after 16 weeks
Interview-style assessment of past head injuries, including their severity and their resulting symptoms.
Symptom Checklist 90-Revised
时间窗: Baseline and after 16 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
Brief Dispositional Resilience Scale
时间窗: Baseline and after 16 weeks
a 15-item measure of psychological hardiness, covering aspects related to commitment, control, and challenge
Valence Bias Task
时间窗: Baseline and after 16 weeks
an assessment to measure an individual's tendency to interpret ambiguous stimuli as having a positive or negative valence
次要结局
- Brain Imaging(Baseline and after 16 weeks)