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Active, Not Recruiting

NCT Number: NCT05581953

Protein-Distinct Macronutrient-Equivalent Diet 2

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, 57007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omnivorous

Other

Pork-added plant-forward diet

No meat

Other

Plant-forward no meat

Primary outcomes

  1. Concentration of Fasting insulin in blood

    Time frame: Time frame: 16 weeks

    Using Microplate assay

  2. Concentration of Ferritin in blood

    Time frame: Time frame: 16 weeks

    Using Microplate assay

  3. Concentration of Homocysteine in blood

    Time frame: Time frame: 16 weeks

    Using Microplate assay

  4. Frequency of Sit-to-stand for strength assessment

    Time frame: Time frame: 16 weeks

    Functional assessment test

Secondary outcomes

  1. Fasting blood glucose concentration in blood

    Time frame: Time frame: 16 weeks

    Using Glucometer

  2. Concentration of FGF21 in blood

    Time frame: Time frame: 16 weeks

    Using Microplate assay

  3. HOMA-IR index using insulin and glucose concentration in blood

    Time frame: Time frame: 16 weeks

    Standard equation

  4. Concentration of ApoB in blood

    Time frame: Time frame: 16 weeks

    Using Microplate assay

  5. Concentration of Lipid panel in blood

    Time frame: Time frame: 16 weeks

    Cholestech ldx

  6. Concentration of IGF-1 in blood

    Time frame: Time frame: 16 weeks

    Using Microplate assay

  7. Concentration of Complex lipids panel in blood

    Time frame: Time frame: 16 weeks

    Using LC/MS based assay

  8. Concentration of C-peptide

    Time frame: Time frame: 16 weeks

    Using Microplate assay

  9. Concentration of HsCRP in blood

    Time frame: Time frame: 16 weeks

    Using Microplate assay

  10. Height in cm

    Time frame: Time frame: 16 weeks

    Measurements

  11. Body Weight in kg

    Time frame: Time frame:16 weeks

    Measurements

  12. Blood pressure in mm Hg

    Time frame: Time frame: 16 weeks

    Upper arm cuff

  13. heart rate in beats per minute

    Time frame: Time frame: 16 weeks

    Upper arm cuff

  14. Grip force per kg mass

    Time frame: Time frame: 16 weeks

    Using Dynamometer

Sponsors and collaborators

Lead sponsor

South Dakota State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Oct 17, 2022
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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