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

Launched by UNIVERSITY OF ARKANSAS · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how eating lean pork loin, a high-quality source of protein, affects blood sugar levels and the body's protein use in adults with prediabetes. Participants will be compared to those consuming a lower-quality plant-based protein diet. The goal is to see which diet better supports healthy protein balance and blood sugar control, which is important for managing or preventing diabetes.

To be eligible for the trial, participants should be healthy men or women aged 40 to 60 years, with a body mass index (BMI) between 25 and 35, and have a blood sugar level that indicates prediabetes (an HbA1c level between 5.7% and 6.4%). Participants must be willing to avoid alcohol and certain substances during the four-day study period. Those who do not eat animal proteins, have specific health conditions, or take certain medications may not qualify. If selected, participants will follow a specific diet and provide information about their health and nutrition, helping researchers understand the effects of these diets on their health.

Gender

ALL

Eligibility criteria

• 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