Investigating the Cognitive and Brain Health Benefits of Lean Pork Consumption

University of Nebraska

Status: Withdrawn

Conditions: Dietary Intervention; Older Adults (65 Years and Older); Dietary Assessment; Cognitive Ability, General; Dietary Proteins

Treatments: Dietary Supplement: Ready-to-eat lean pork in frozen, 5-oz packages

Study type: Interventional

Funder types: Other

Identifiers

NCT07031076

23280

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 65 to 75 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 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

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 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Experimental Group

Experimental group

Description:

The experimental group will participate in the 16-week lean pork dietary intervention study. Participants will be provided with 4 portions of ready-to-eat lean pork in frozen packages per week. Each portion of ready-to-eat lean pork provided to this group will weigh 5 ounces.

Treatment:

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

Control Group

No Intervention group

Description:

The control group will not participate in any dietary intervention, other than being instructed to maintain their regular diet.