Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults (NCT06025292) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
United States20 participantsStarted 2024-09-11
Plain-language 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.
Who can participate
Age range40 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, marij…