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The investigative team has transferred to another university.
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| Name | Class |
|---|---|
| National Pork Board | OTHER |
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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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | No Intervention | The control group will not participate in any dietary intervention, other than being instructed to maintain their regular diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Height | measured in feet and inches | Baseline and after 16 weeks |
| Weight | measured in pounds (lbs) | Baseline and after 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aron Barbey, PhD | University of Nebraska Lincoln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska-Lincoln | Lincoln | Nebraska | 68588 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31277446 | Background | 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. | |
| 34083695 | 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. |
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Study findings will be submitted to peer-reviewed journals such as those that follow the ICMJE's recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals. The data collected during this project may be shared through public-use files, repositories or other means outside of the approved research team as a requirement of publication. All data will be identified with subject IDs only when shared. Research records such as informed consent forms, MRI Safety Screening forms, research compliance records, masterlist linking names to subject IDs will not be shared.
IPD and supporting information will be available beginning 1 year after the publication of results with no end date.
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.
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| 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 |
| Baseline and after 16 weeks |
| Body Mass Index | Calculated by body mass divided by the square of the body height, unit in kg/m^2 | Baseline and after 16 weeks |
| Heart Rate | Heart rate will be measured over 5-minute intervals, when the participants are sitting up right on a chair without any physical exhaustion condition. Heart rate will be reported as beat per minute by averaging the heart activity over the 5-minute intervals. | Baseline and after 16 weeks |
| Heart Rate Variability | Heart rate variability will be measured as the standard deviation of R-R interval in millisecond as unit. | Baseline and after 16 weeks |
| Systolic and diastolic Blood Pressure | Measured in mmHg | Baseline and after 16 weeks |
| Body Composition | Body composition will be measured in body fat%, using a bioimpedance scale | Baseline and after 16 weeks |
| Grip Strength | Participants will squeeze a hydraulic device three times with their right hand. Grip strength will be obtained by averaging the three measurements, which will be measured in kilograms. | Baseline and after 16 weeks |
| Blood-based biomarkers associated with consumption of lean pork | Biomarkers under evaluation include inflammatory biomarkers and nutrient biomarkers in blood from participants in the experimental group | Baseline and after 16 weeks |
| 32456281 | 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. |
| ID | Term |
|---|---|
| D005615 | Freezing |
| ID | Term |
|---|---|
| D044367 | Phase Transition |
| D055585 | Physical Phenomena |
| D003080 | Cold Temperature |
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055598 | Chemical Phenomena |
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