South Dakota State University, Wagner Hall 416
Brookings, South Dakota, 57007, United States
NCT Number: NCT05581953
The central hypothesis is that the addition of minimally processed lean pork to a healthy plant-forward low ultra-processed diet will enhance nutrient adequacy, promote muscular fitness, and maintain 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 minimally processed 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 minimally processed plant-forward diet with or without added pork will be compared 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.
This study is active but is not currently recruiting participants.
65 year and older
All sexes
Interventional
Not applicable
Brookings, South Dakota, 57007, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pork-added plant-forward diet
Plant-forward no meat
Time frame: Time frame: 16 weeks
Using Microplate assay
Time frame: Time frame: 16 weeks
Using Microplate assay
Time frame: Time frame: 16 weeks
Using Microplate assay
Time frame: Time frame: 16 weeks
Functional assessment test
Time frame: Time frame: 16 weeks
Using Glucometer
Time frame: Time frame: 16 weeks
Using Microplate assay
Time frame: Time frame: 16 weeks
Standard equation
Time frame: Time frame: 16 weeks
Using Microplate assay
Time frame: Time frame: 16 weeks
Cholestech ldx
Time frame: Time frame: 16 weeks
Using Microplate assay
Time frame: Time frame: 16 weeks
Using LC/MS based assay
Time frame: Time frame: 16 weeks
Using Microplate assay
Time frame: Time frame: 16 weeks
Using Microplate assay
Time frame: Time frame: 16 weeks
Measurements
Time frame: Time frame:16 weeks
Measurements
Time frame: Time frame: 16 weeks
Upper arm cuff
Time frame: Time frame: 16 weeks
Upper arm cuff
Time frame: Time frame: 16 weeks
Using Dynamometer
South Dakota State University
Other
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
Acronym: PRODMED2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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