Protein-Distinct Macronutrient-Equivalent Diet 2 (PRODMED2)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Aging
• Intervention / Treatment: Other: Omnivorous; Other: No meat

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Brookings, South Dakota, United States, 57007
      • South Dakota State University, Wagner Hall 416

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Generally good health status based on one routine physical in the past 15 months
• 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
• Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
• Willing to consume pork as sole meat source during the feeding study.

Exclusion Criteria:

• Tobacco/drug/alcohol use
• Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
• 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 were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-ultra-processed Omnivorous; Minimally processed animal protein-lean pork within a low UPF dietary pattern	Other: Omnivorous; Pork-added plant-forward diet
Other: Low-ultra-processed No meat; Plant-forward no meat	Other: No meat; Plant-forward no meat

What is the study measuring?

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
Concentration of Fasting insulin in blood	Using Microplate assay	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 ApoB in blood	Using Microplate assay	Time frame: 16 weeks
Concentration of Lipid panel in blood	Cholestech ldx	Time frame: 16 weeks
Concentration of IGF-1 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 HsCRP in blood	Using Microplate assay	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
Concentration of FGF21 in blood	Using Microplate assay	Time frame: 16 weeks
Concentration of C-peptide	Using Microplate assay	Time frame: 16 weeks

Collaborators and Investigators

• Sponsor: South Dakota State University
• Investigators: Principal Investigator: Moul Dey, Ph.D., South Dakota State University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB-2209010-EXP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No