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

NCT06025292 | Recruiting

• 1 other identifier: 276210
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycaemia (Non Diabetic); Prediabetes

Keywords

Lean pork; Muscle Protein Synthesis; Protein; Plant-Based

Outcome Measures

Primary Outcomes (2)

• Muscle Protein Synthesis

  Mixed muscle protein synthesis expressed as the fractional synthetic rate.

  24 hours

• Whole Body Protein Balance

  Amount of net protein gained per unit of time.

  24 hours

Secondary Outcomes (2)

• Whole Body Protein Synthesis

  24 hours

• 24-hour Mean Glucose

  24 hours

Other Outcomes (3)

• Whole Body Protein Breakdown

  24 hours

• Whole Body Protein Flux

  24 hours

• Glucose Regulation and Homeostasis

  24 hours

Study Arms (2)

High Quality Protein Intake - Lean Pork

ACTIVE COMPARATOR

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

Low Quality Protein Intake - Plant-Based

ACTIVE COMPARATOR

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

Interventions

Lean Pork vs Plant-Based Protein OTHER

Participants will eat prepared study meals for three days that have either protein sourced from lean pork or plant-based sources.

High Quality Protein Intake - Lean Pork; Low Quality Protein Intake - Plant-Based

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Participant who does not/will not eat animal protein sources.
• \. Allergy to wheat, soy, or common ingredients in plant-based protein products.
• \. Body mass index \<25 kg/m2 or \>40 kg/m2.
• \. Hemoglobin \<10g/dL at screening.
• \. Platelets \<150,000/uL at screening.
• \. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
• \. History of gastrointestinal bypass/reduction surgery.
• \. Pregnant or lactating individuals.
• \. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
• \. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
• \. Currently using prescription blood thinning medications.
• \. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
• \. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3 and Visit 7.
• \. Unwilling to avoid using protein or amino-acid supplements during participation.
• \. Unwilling to fast overnight.

Sponsors & Collaborators

• University of Arkansas: lead
• National Pork Board: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Prediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• David Church, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Church, PhD

CONTACT

501-526-5769; dchurch@uams.edu

Amanda Gwin, PA-C

CONTACT

5018380096; algwin@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: September 11, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)