Role of Lean-pork Within a Plant-based Dietary Pattern

South Dakota State University

Status: Active, not recruiting

Conditions: Healthy Aging

Treatments: Other: Vegetarian; Other: Omnivorous

Study type: Interventional

Funder types: Other

Identifiers

NCT05581953

IRB-2209010-EXP

Details and patient eligibility

About

The central hypothesis is that the addition of lean pork to a healthy plant-only diet will enhance nutrient adequacy to attenuate markers of cognitive decline, promote muscular fitness, and maintain immuno-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 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 plant-forward pork-added diet will be compared with an isocaloric plant-only control 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, current health status
• 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, and
• willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion criteria

• medication usage, probiotic, long-term antibiotic, and tobacco/drug/alcohol use
• Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
• impaired kidney functions
• 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 had not had a routine health checkup during the 12 months prior to recruitment.
• If they were unwilling to abstain from taking nutritional supplements, alcohol, non-study foods, and beverage during the study period.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

59 participants in 2 patient groups

Omnivorous

Experimental group

Description:

Animal protein-lean pork

Treatment:

Other: Omnivorous

Vegetarian

Other group

Description:

Lacto-ovo-vegetarian without any meat

Treatment:

Other: Vegetarian