Protein-Distinct Macronutrient-Equivalent Diet 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Protein-Distinct Macronutrient-Equivalent Diet 1

NCT05577858

Healthy Lifestyle

ACTIVE_NOT_RECRUITING NA

Effect of Minimally Processed Animal Protein on Biomarkers for Cognitive Decline

NCT06261775

Healthy Lifestyle

ACTIVE_NOT_RECRUITING NA

Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly

NCT01415973

Healthy

COMPLETED NA

The Effect of the DASH Diet Containing Meat on Muscle and Metabolic Health in Older Adults

NCT04127240

Obesity Sarcopenia Aging

COMPLETED NA

Dietary Interventions for Muscle Mass

NCT01145131

Aging

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low-ultra-processed Omnivorous

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

Group Type EXPERIMENTAL

Omnivorous

Intervention Type OTHER

Pork-added plant-forward diet

Low-ultra-processed No meat

Plant-forward no meat

Group Type OTHER

No meat

Intervention Type OTHER

Plant-forward no meat

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omnivorous

Pork-added plant-forward diet

Intervention Type OTHER

No meat

Plant-forward no meat

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes