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

Not Applicable

Recruiting

• Conditions: Hyperglycaemia (Non Diabetic); Prediabetes
• Interventions: Other: Lean Pork vs Plant-Based Protein

• Registration Number: NCT06025292
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Status Verified: 2024-08
• Study Start: 2024-09-11
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-12-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1. Males and females ages 40-60 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%

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. Currently receiving GIP-1 or GLP-1 therapy (excluding semaglutide, see below)
• 18. Participants on semaglutide for <3 months or with less than one treatment dose (injection) every two weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Quality Protein Intake - Lean Pork	Lean Pork vs Plant-Based Protein	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.
Low Quality Protein Intake - Plant-Based	Lean Pork vs Plant-Based Protein	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States