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

University of Arkansas

Status: Enrolling

Conditions: Prediabetes; Hyperglycaemia (Non Diabetic)

Treatments: Other: Lean Pork vs Plant-Based Protein

Study type: Interventional

Funder types: Other

Identifiers

NCT06025292

276210

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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. Participants on glucagon-like-peptide-1 receptor agonist (GLP-1-RA) medications for <3 months or with less than one treatment dose (injection) every two weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

High Quality Protein Intake - Lean Pork

Active Comparator group

Description:

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.

Treatment:

Other: Lean Pork vs Plant-Based Protein

Low Quality Protein Intake - Plant-Based

Active Comparator group

Description:

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).

Treatment:

Other: Lean Pork vs Plant-Based Protein