Protein-Distinct Macronutrient-Equivalent Diet 2

Not Applicable

Active, not recruiting

• Conditions: Healthy Aging
• Interventions: Other: Omnivorous; Other: Vegetarian

• Registration Number: NCT05581953
• Lead Sponsor: South Dakota State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Study Start: 2022-11-15
• Primary Completion: 2023-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Omnivorous	Omnivorous	Animal protein-lean pork
Vegetarian	Vegetarian	Lacto-ovo-vegetarian without any meat

Primary Outcome Measures

Name	Time	Method
Concentration of Fasting insulin in blood	Time frame: 16 weeks	Using Microplate assay
Concentration of Ferritin in blood	Time frame: 16 weeks	Using Microplate assay
Concentration of Homocysteine in blood	Time frame: 16 weeks	Using Microplate assay
Frequency of Sit-to-stand for strength assessment	Time frame: 16 weeks	Functional assessment test

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose concentration in blood	Time frame: 16 weeks	Using Glucometer
Concentration of FGF21 in blood	Time frame: 16 weeks	Using Microplate assay
HOMA-IR index using insulin and glucose concentration in blood	Time frame: 16 weeks	Standard equation
Concentration of ApoB in blood	Time frame: 16 weeks	Using Microplate assay
Concentration of Lipid panel in blood	Time frame: 16 weeks	Cholestech ldx
Concentration of IGF-1 in blood	Time frame: 16 weeks	Using Microplate assay
Concentration of Complex lipids panel in blood	Time frame: 16 weeks	Using LC/MS based assay
Concentration of C-peptide	Time frame: 16 weeks	Using Microplate assay
Concentration of HsCRP in blood	Time frame: 16 weeks	Using Microplate assay
Height in cm	Time frame: 16 weeks	Measurements
Body Weight in kg	Time frame:16 weeks	Measurements
Blood pressure in mm Hg	Time frame: 16 weeks	Upper arm cuff
heart rate in beats per minute	Time frame: 16 weeks	Upper arm cuff
Grip force per kg mass	Time frame: 16 weeks	Using Dynamometer

Trial Locations

Locations (1)

South Dakota State University, Wagner Hall 416; 🇺🇸 Brookings, South Dakota, United States