Investigating the Cognitive and Brain Health Benefits of Lean Pork Consumption

NCT07031076 | Withdrawn

• 1 other identifier: 23280
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

pork consumption; pork dietary intervention; brain health; cognitive health

Outcome Measures

Primary Outcomes (22)

• WAIS-V

  Wechsler Adult Intelligence Scale, verison 5. Comprehensive assessment battery for measuring cognitive abilities

  Baseline and after 16 weeks

• Trail Making Test

  Delis-Kaplan Executive Function System test for sequencing and cognitive flexibility

  Baseline and after 16 weeks

• NIH Toolbox (Dimensional Change Card Sort)

  Test for executive function and cognitive flexibility

  Baseline and after 16 weeks

• NIH Toolbox (Flanker)

  test for executive functions: attention and inhibitory control

  Baseline and after 16 weeks

• NIH Toolbox (List Sorting Working Memory Test)

  Test for working memory

  Baseline and after 16 weeks

• Adult Decision-Making Competence test

  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

  Baseline and after 16 weeks

• Cognitive Reflection Test

  Test to measure the ability to suppress an intuitive wrong answer in favor of a more reflective correct answer

  Baseline and after 16 weeks

• Attentional Network Task

  Computerized task to measure the effects of visual and auditory cues on visual processing

  Baseline and after 16 weeks

• UCLA Loneliness Scale

  measure of subjective loneliness and social isolation

  Baseline and after 16 weeks

• Short Form-36 Health Survey

  self-report measure of health status and quality of life

  Baseline and after 16 weeks

• Psychological Wellbeing Scale

  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

  Baseline and after 16 weeks

• Decision Outcome Inventory

  an assessment of outcomes of real-life decisions

  Baseline and after 16 weeks

• The Mindset Survey

  an assessment to determine whether an individual has a fixed mindset or a growth mindset

  Baseline and after 16 weeks

• Need for Cognition Scale

  assessment of an individual's tendency to engage in and enjoy thinking or mental exertion

  Baseline and after 16 weeks

• Pittsburgh Sleep Quality Index

  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

  Baseline and after 16 weeks

• Consortium to Establish a Registry for Alzhiemer's Disease Word List Acquisition and Delayed Recall

  A learning and delay memory recall task that is used to quickly assess an individual's mental capacity in memory.

  Baseline and after 16 weeks

• Geriatric Depression Scale

  Assessment of an older adult's status of mental health that screens for depression

  Baseline and after 16 weeks

• Ohio State Traumatic Brain Injury Identification

  Interview-style assessment of past head injuries, including their severity and their resulting symptoms.

  Baseline and after 16 weeks

• Symptom Checklist 90-Revised

  self-report assessment of psychological symptoms related to the domains of somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism

  Baseline and after 16 weeks

• Grit

  self-report measure of perseverance

  Baseline and after 16 weeks

• Brief Dispositional Resilience Scale

  a 15-item measure of psychological hardiness, covering aspects related to commitment, control, and challenge

  Baseline and after 16 weeks

• Valence Bias Task

  an assessment to measure an individual's tendency to interpret ambiguous stimuli as having a positive or negative valence

  Baseline and after 16 weeks

Secondary Outcomes (1)

• Brain Imaging

  Baseline and after 16 weeks

Other Outcomes (9)

• Height

  Baseline and after 16 weeks

• Weight

  Baseline and after 16 weeks

• Body Mass Index

  Baseline and after 16 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

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

Control Group

NO INTERVENTION

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

Interventions

Ready-to-eat lean pork in frozen, 5-oz packages DIETARY_SUPPLEMENT

The dietary intervention lasts 16 weeks for each individual. Participants in the experimental group will receive this intervention. Each participant will acquire 4 portions of ready-to eat lean pork in frozen packages per week; each portion of ready-to-eat lean pork in this intervention will weigh 5 ounces.

Experimental Group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Nebraska Lincoln: lead
• National Pork Board: collaborator

Study Sites (1)

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588, United States

Location

Related Publications (3)

• Wade AT, Davis CR, Dyer KA, Hodgson JM, Woodman RJ, Keage HAD, Murphy KJ. A Mediterranean Diet with Fresh, Lean Pork Improves Processing Speed and Mood: Cognitive Findings from the MedPork Randomised Controlled Trial. Nutrients. 2019 Jul 4;11(7):1521. doi: 10.3390/nu11071521.

  PMID: 31277446 BACKGROUND

• Hepsomali P, Groeger JA. Diet and general cognitive ability in the UK Biobank dataset. Sci Rep. 2021 Jun 3;11(1):11786. doi: 10.1038/s41598-021-91259-3.

  PMID: 34083695 BACKGROUND

• Zhang H, Hardie L, Bawajeeh AO, Cade J. Meat Consumption, Cognitive Function and Disorders: A Systematic Review with Narrative Synthesis and Meta-Analysis. Nutrients. 2020 May 24;12(5):1528. doi: 10.3390/nu12051528.

  PMID: 32456281 BACKGROUND

MeSH Terms

Interventions

Freezing

Intervention Hierarchy (Ancestors)

Phase Transition; Physical Phenomena; Cold Temperature; Temperature; Thermodynamics; Chemical Phenomena

Study Officials

• Aron Barbey, PhD

  University of Nebraska Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available beginning 1 year after the publication of results with no end date.
• Access Criteria: Researchers who provide a methodologically sound proposal will be able to access the IPD and supporting information. Researchers are not restricted on the type of analyses, as long as they are methodologically sound. The statistical methods for those analyses must be approved before the researchers can gain access to the data. For data sharing, a proposal that describes planned analyses must be submitted to the study's contact personnel for review. A data sharing agreement must be signed between the institution of the requesting researchers and the institution of the study's principal investigator.

Locations

US (1)