Protein-Distinct Macronutrient-Equivalent Diet 2

NCT05581953 | Active Not Recruiting

• 1 other identifier: IRB-2209010-EXP
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Concentration of Fasting insulin in blood

  Using Microplate assay

  Time frame: 16 weeks

• Concentration of Ferritin in blood

  Using Microplate assay

  Time frame: 16 weeks

• Concentration of Homocysteine in blood

  Using Microplate assay

  Time frame: 16 weeks

• Frequency of Sit-to-stand for strength assessment

  Functional assessment test

  Time frame: 16 weeks

Secondary Outcomes (14)

• Fasting blood glucose concentration in blood

  Time frame: 16 weeks

• Concentration of FGF21 in blood

  Time frame: 16 weeks

• HOMA-IR index using insulin and glucose concentration in blood

  Time frame: 16 weeks

• Concentration of ApoB in blood

  Time frame: 16 weeks

• Concentration of Lipid panel in blood

  Time frame: 16 weeks

Study Arms (2)

Low-ultra-processed Omnivorous

EXPERIMENTAL

Minimally processed animal protein-lean pork within a low UPF dietary pattern

Other: Omnivorous

Low-ultra-processed No meat

OTHER

Plant-forward no meat

Other: No meat

Interventions

Omnivorous OTHER

Pork-added plant-forward diet

Low-ultra-processed Omnivorous

No meat OTHER

Plant-forward no meat

Low-ultra-processed No meat

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Dakota State University: lead

Study Sites (1)

South Dakota State University, Wagner Hall 416

Brookings, South Dakota, 57007, United States

Location

Related Publications (4)

• 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.

  PMID: 41551721 DERIVED

• 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.

  PMID: 41202666 DERIVED

• 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.

  PMID: 40832369 DERIVED

• 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.

  PMID: 40291832 DERIVED

Study Officials

• Moul Dey, Ph.D.

  South Dakota State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Blinding will be implemented to the extent possible. A researcher, unaware of the study goals and not involved with downstream data analyses will use a 1:1 block randomization to allocate participants to the diets in the first arm. Food service personnel (care provider) will not be aware of study goals and allocations. Metabolomic assays will be run in a blinded manner.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: November 15, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-01

Locations

US (1)