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Protein-Distinct Macronutrient-Equivalent Diet 2

NCT05581953 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Aging

Interventions

OTHER

Omnivorous

Pork-added plant-forward diet

OTHER

No meat

Plant-forward no meat

Sponsors & Collaborators

  • South Dakota State University

    lead OTHER

Principal Investigators

  • Moul Dey, Ph.D. · South Dakota State University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2023-12-20
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581953 on ClinicalTrials.gov