Active — Not RecruitingNot Applicable

Protein-Distinct Macronutrient-Equivalent Diet 2

United States59 participantsStarted 2022-11-15

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Concentration of Fasting insulin in blood

Timeframe: Time frame: 16 weeks

Concentration of Ferritin in blood

Timeframe: Time frame: 16 weeks

Concentration of Homocysteine in blood

Timeframe: Time frame: 16 weeks

Frequency of Sit-to-stand for strength assessment

Timeframe: Time frame: 16 weeks

Trial details

NCT IDNCT05581953

SponsorSouth Dakota State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-20

View on ClinicalTrials.gov More Healthy Aging trials

Plain-language summary

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.