Role of Lean-pork Within a Plant-based Dietary Pattern

Study Overview
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Brief Summary
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The central hypothesis is that the addition of lean pork to a healthy plant-only diet will enhance nutrient adequacy to attenuate markers of cognitive decline, promote muscular fitness, and maintain immuno-metabolic functions for improved healthspan. A well-designed, randomized, controlled, crossover, feeding study with clinical and molecular mechanistic endpoints is proposed to provide the most definitive level of evidence logistically possible in humans and to establish the role of lean pork in healthspan promotion. Utilizing an all-food-provided (dine-in and take-out) design over 18 weeks (rolling recruitment, 8+8, 2w washout), a comprehensive assessment of metabolomics, system biology, physical, and physiological markers that indicate the risk of age-related comorbidities-critical micronutrient deficiency, frailty, metabolic dysfunctions, and cognitive decline, is proposed in upper Midwesterners 65 years and older. A plant-forward pork-added diet will be compared with an isocaloric plant-only control for over 250 outcome measures using mixed-effects modeling adjusting for covariates in R. n=15/diet/arm i.e., a total starting sample size of n=30 is proposed for 90% power.

Official Title
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The Role of Lean-pork Within a Plant-based Dietary Pattern for Improving Iron Reserve, Muscle-fitness, and Markers of Health Span in Older Adults: A Multi-disciplinary Randomized Controlled Feeding Study

Conditions
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Healthy Aging

Intervention / Treatment
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* Other: Omnivorous
* Other: Vegetarian


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: generally good health status based on one routine physical in the past 15 months, current health status normal HbA1C, weigh 110 lb or more Age 65 years or more, generally healthy, all races and both sexes generally practicing a meat-based dietary pattern, do not have any special dietary requirement, and willingness to comply with the study protocol, including on-site meal consumption and sample/data collection. Exclusion Criteria: medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight. impaired kidney functions Active history of cancer, diabetes, heart, liver, and kidney diseases major gastrointestinal disorders in the past 3 months history of heart attacks or stroke Unable to meet in-person visit requirements for dining, picking up meals, and tests Any mental health condition that would affect the ability to provide written informed consent. If they had not had a routine health checkup during the 12 months prior to recruitment. If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omnivorous<br>Animal protein-lean pork | Other: Omnivorous<br>* Pork-added plant-forward diet<br>|
| Other: Vegetarian<br>Lacto-ovo-vegetarian without any meat | Other: Vegetarian<br>* Plant-forward lacto-ovo-vegetarian diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Homocysteine in blood | Using Microplate assay | Time frame: 16 weeks | 
| Concentration of Ferritin in blood | Using Microplate assay | Time frame: 16 weeks | 
| Frequency of Sit-to-stand for strength assessment | Functional assessment test | Time frame: 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose concentration in blood | Using Glucometer | Time frame: 16 weeks | 
| Concentration of ApoA in blood | Using Microplate assay | Time frame: 16 weeks | 
| Concentration of ApoB in blood | Using Microplate assay | Time frame: 16 weeks | 
| Concentration of Lipid panel in blood | Cholestech ldx | Time frame: 16 weeks | 
| Concentration of Iron status in blood | Using Microplate assay | Time frame: 16 weeks | 
| Concentration of vit B12 in blood | Using Microplate assay | Time frame: 16 weeks | 
| Concentration of IGF-1 in blood | Using Microplate assay | Time frame: 16 weeks | 
| Concentration of IGF-BP3 in blood | Using Microplate assay | Time frame: 16 weeks | 
| Concentration of Fasting insulin in blood | Using Microplate assay | Time frame: 16 weeks | 
| HOMA-IR index using insulin and glucose concentration in blood | Standard equation | Time frame: 16 weeks | 
| Concentration of Complex lipids panel in blood | Using LC/MS based assay | Time frame: 16 weeks | 
| Concentration of IL-6 in blood | Using Microplate assay | Time frame: 16 weeks | 
| Concentration of HsCRP in blood | Using Microplate assay | Time frame: 16 weeks | 
| Vascular age score, calculated using lipid markers in blood | Standard equation | Time frame: 16 weeks | 
| Height in cm | Measurements | Time frame: 16 weeks | 
| Body Weight in kg | Measurements | Time frame:16 weeks | 
| Blood pressure in mm Hg | Upper arm cuff | Time frame: 16 weeks | 
| heart rate in beats per minute | Upper arm cuff | Time frame: 16 weeks | 
| Grip force per kg mass | Using Dynamometer | Time frame: 16 weeks | 
| Muscle strength using Isokinetic muscle testing | Biodex Ergometer | Time frame: 16 weeks | 
| Balance assessment using balance and gait score | Mechanography | Time frame: 16 weeks |