Clinical trial NCT06025292: Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Official title: Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperglycaemia (Non Diabetic)
Prediabetes
Keywords: Lean pork
Muscle Protein Synthesis
Protein
Plant-Based
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Pork Board
First posted: 2023-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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. Currently receiving GIP-1 or GLP-1 therapy (excluding semaglutide, see below)
* 18. Participants on semaglutide for \<3 months or with less than one treatment dose (injection) every two weeks

Primary outcomes:
measure: Muscle Protein Synthesis
timeFrame: 24 hours
measure: Whole Body Protein Balance
timeFrame: 24 hours
Secondary outcomes:
measure: Whole Body Protein Synthesis
timeFrame: 24 hours
measure: 24-hour Mean Glucose
timeFrame: 24 hours
Other outcomes:
measure: Whole Body Protein Breakdown
timeFrame: 24 hours
measure: Whole Body Protein Flux
timeFrame: 24 hours
measure: Glucose Regulation and Homeostasis
timeFrame: 24 hours
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: David Church, PhD
role: PRINCIPAL_INVESTIGATOR
References: