Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults (PORK)

We will be directly comparing a high-quality protein diet composed primarily of lean pork loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with prediabetes on muscle and whole-body protein turnover and glucose regulation.

Study Overview

• Status: Recruiting
• Conditions: Prediabetes; Hyperglycaemia (Non Diabetic)
• Intervention / Treatment: Other: Lean Pork vs Plant-Based Protein

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Church, PhD; Phone Number: 501-526-5769; Email: dchurch@uams.edu
• Study Contact Backup: Name: Amanda Gwin, PA-C; Phone Number: 5018380096; Email: algwin@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences
      • Contact: David D Church, PhD; Email: dchurch@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Males and females ages 40-65 years.
• 2. BMI 25 to ≤40 kg/m2 (or body fat % ≥25% in males or ≥36% in females)
• 3. Capable of providing informed consent.
• 4. COVID-19 negative and/or asymptomatic.
• 5. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 4-day study meal period
• 6. HbA1c: 5.7-6.4% or fasting glucose 100-125 mg/dL

Exclusion Criteria:

• 1. Participant who does not/will not eat animal protein sources.
• 2. Allergy to wheat, soy, or common ingredients in plant-based protein products.
• 3. Body mass index <25 kg/m2 or >40 kg/m2.
• 4. Hemoglobin <10g/dL at screening.
• 5. Platelets <150,000/uL at screening.
• 6. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
• 7. History of gastrointestinal bypass/reduction surgery.
• 8. Pregnant or lactating individuals.
• 9. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
• 10. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
• 11. Currently using prescription blood thinning medications.
• 12. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
• 13. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3 and Visit 7.
• 14. Unwilling to avoid using protein or amino-acid supplements during participation.
• 15. Unwilling to fast overnight.
• 16. Unwilling to avoid alcohol, marijuana and CBD products for the four study days.
• 17. Participants on glucagon-like-peptide-1 receptor agonist (GLP-1-RA) medications for <1 month or with less than one treatment dose (injection) every two weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Quality Protein Intake - Lean Pork; Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from lean pork.	Other: Lean Pork vs Plant-Based Protein; Participants will eat prepared study meals for three days that have either protein sourced from lean pork or plant-based sources.
Active Comparator: Low Quality Protein Intake - Plant-Based; Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from plant-based protein (ie impossible burger, black bean burger, soy, etc).	Other: Lean Pork vs Plant-Based Protein; Participants will eat prepared study meals for three days that have either protein sourced from lean pork or plant-based sources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole Body Protein Balance	Amount of net protein gained per unit of time.	24 hours
Muscle Protein Synthesis	Mixed muscle protein synthesis expressed as the fractional synthetic rate.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole Body Protein Synthesis	Amount of protein produced per unit of time.	24 hours
24-hour Mean Glucose	Derived from continous glucose monitor data.	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole Body Protein Flux	Amount of protein turnover per unit of time.	24 hours
Whole Body Protein Breakdown	Amount of protein broken down per unit of time.	24 hours
Glucose Regulation and Homeostasis	Derived from continuous glucose monitor data.	24 hours

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: National Pork Board
• Investigators: Principal Investigator: David Church, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Protein; Muscle Protein Synthesis; Lean pork; Plant-Based
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hyperglycemia; Prediabetic State
• Other Study ID Numbers: 276210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No