AzTrials
AzTrials

Healthy AgingPRODMED2NCT05581953

Protein-Distinct Macronutrient-Equivalent Diet 2

A study testing Omnivorous and No meat in people with Healthy Aging, run by South Dakota State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Aging
What is being tested?
Omnivorous and No meat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
15 Nov 2022to 19 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • South Dakota State University, Wagner Hall 416

    Brookings, South Dakota, 57007

Other trials in United States

About this study

Official 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

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
Being tested
Omnivorous, No meat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmnivorousOther

    Pork-added plant-forward diet

  • No meatOther

    Plant-forward no meat

Study groups in NCT05581953
Study groupRoleWhat they receive
Low-ultra-processed OmnivorousExperimentalMinimally processed animal protein-lean pork within a low UPF dietary pattern
Receives: Other: Omnivorous
Low-ultra-processed No meatOtherPlant-forward no meat
Receives: Other: No meat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of Fasting insulin in blood

    Using Microplate assay

    Measured: Time frame: 16 weeks

  2. Concentration of Ferritin in blood

    Using Microplate assay

    Measured: Time frame: 16 weeks

  3. Concentration of Homocysteine in blood

    Using Microplate assay

    Measured: Time frame: 16 weeks

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

    Functional assessment test

    Measured: Time frame: 16 weeks

Secondary outcomes (14)

  1. Fasting blood glucose concentration in blood

    Using Glucometer

    Measured: Time frame: 16 weeks

  2. Concentration of FGF21 in blood

    Using Microplate assay

    Measured: Time frame: 16 weeks

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

    Standard equation

    Measured: Time frame: 16 weeks

  4. Concentration of ApoB in blood

    Using Microplate assay

    Measured: Time frame: 16 weeks

  5. Concentration of Lipid panel in blood

    Cholestech ldx

    Measured: Time frame: 16 weeks

  6. Concentration of IGF-1 in blood

    Using Microplate assay

    Measured: Time frame: 16 weeks

  7. Concentration of Complex lipids panel in blood

    Using LC/MS based assay

    Measured: Time frame: 16 weeks

  8. Concentration of C-peptide

    Using Microplate assay

    Measured: Time frame: 16 weeks

  9. Concentration of HsCRP in blood

    Using Microplate assay

    Measured: Time frame: 16 weeks

  10. Height in cm

    Measurements

    Measured: Time frame: 16 weeks

  11. Body Weight in kg

    Measurements

    Measured: Time frame:16 weeks

  12. Blood pressure in mm Hg

    Upper arm cuff

    Measured: Time frame: 16 weeks

  13. heart rate in beats per minute

    Upper arm cuff

    Measured: Time frame: 16 weeks

  14. Grip force per kg mass

    Using Dynamometer

    Measured: Time frame: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2022
  2. Study start15 Nov 2022
  3. Primary completion19 Jan 2024
  4. Study completion19 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581953
Sponsor's protocol ID
IRB-2209010-EXP
Acronym
PRODMED2
Status last verified
Jan 2025
First submitted
12 Oct 2022
Last updated
21 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vaezi S, Freeling JL, de Vargas BO, Weidauer L, Shoemaker ME, Sanders WM, Dey M. Impacts of minimally-processed omnivorous vs lacto-ovo-vegetarian diets on insulin sensitivity, lipid profile, and adiposity in older adults: Secondary findings from a randomized crossover feeding trial. Clin Nutr. 2025 Dec;55:90-103. doi: 10.1016/j.clnu.2025.10.010. Epub 2025 Oct 29.

    PubMed 41202666

  • Vaezi S, de Vargas BO, Weidauer L, Freeling JL, Dey M. Effects of Minimally Processed Red Meat within a Plant-Forward Diet on Biomarkers of Physical and Cognitive Aging: A Randomized Controlled Crossover Feeding Trial. Curr Dev Nutr. 2025 Dec 10;10(1):107615. doi: 10.1016/j.cdnut.2025.107615. eCollection 2026 Jan.

    PubMed 41551721

  • Vaezi S, de Vargas BO, Freeling JL, Weidauer L, Dey M. Effects of Minimally Processed Red Meat Within a Plant-Forward Diet on Biomarkers of Physical and Cognitive Aging: A Randomized Controlled Crossover Feeding Trial. medRxiv [Preprint]. 2025 Aug 13:2025.08.11.25333443. doi: 10.1101/2025.08.11.25333443.

    PubMed 40832369

  • de Vargas BO, Vaezi S, Freeling JL, Zhang Y, Weidauer L, Lee CL, Zhao J, Dey M. Design and Implementation of the Protein-Distinct Macronutrient-Equivalent Diet (PRODMED) Study: An Eighteen-Week Randomized Crossover Feeding Trial Among Free-Living Rural Older Adults. Curr Dev Nutr. 2025 Mar 24;9(5):104588. doi: 10.1016/j.cdnut.2025.104588. eCollection 2025 May.

    PubMed 40291832

Questions about this trial

What is this clinical trial studying?

A study testing Omnivorous and No meat in people with Healthy Aging, run by South Dakota State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Fasting insulin in blood (time frame: Time frame: 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581953, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in