Protein-Distinct Macronutrient-Equivalent Diet 2 (PRODMED2)

South Dakota State University

Status: Active, not recruiting

Conditions: Healthy Aging

Treatments: Other: Omnivorous; Other: No meat

Study type: Interventional

Funder types: Other

Identifiers

NCT05581953

IRB-2209010-EXP

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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59 participants in 2 patient groups

Low-ultra-processed Omnivorous

Experimental group

Description:

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

Treatment:

Other: Omnivorous

Low-ultra-processed No meat

Other group

Description:

Plant-forward no meat

Treatment:

Other: No meat