Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Purpose
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
Eligibility
- Eligible Ages
- Between 40 Years and 65 Years
- Eligible 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/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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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). |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
More Details
- NCT ID
- NCT06025292
- Status
- Recruiting
- Sponsor
- University of Arkansas