Status:
RECRUITING
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
National Pork Board
Conditions:
Hyperglycaemia (Non Diabetic)
Prediabetes
Eligibility:
All Genders
40-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06025292
Start Date
September 11 2024
End Date
November 30 2026
Last Update
July 18 2025
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205