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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05581953
Study type Interventional
Source South Dakota State University
Contact
Status Active, not recruiting
Phase N/A
Start date November 15, 2022
Completion date December 31, 2024

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