Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Arkansas
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Muscle Protein Synthesis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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
- •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
Arms & Interventions
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.
Intervention: Lean Pork vs Plant-Based Protein (Other)
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).
Intervention: Lean Pork vs Plant-Based Protein (Other)
Outcomes
Primary Outcomes
Muscle Protein Synthesis
Time Frame: 24 hours
Mixed muscle protein synthesis expressed as the fractional synthetic rate.
Whole Body Protein Balance
Time Frame: 24 hours
Amount of net protein gained per unit of time.
Secondary Outcomes
- Whole Body Protein Synthesis(24 hours)
- 24-hour Mean Glucose(24 hours)