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NCT Number: NCT06025292

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

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.

Recruiting

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location status: Recruiting

Location contact

David D Church, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lean Pork vs Plant-Based Protein

Other

Participants will eat prepared study meals for three days that have either protein sourced from lean pork or plant-based sources.

Primary outcomes

  1. Muscle Protein Synthesis

    Time frame: 24 hours

    Mixed muscle protein synthesis expressed as the fractional synthetic rate.

  2. Whole Body Protein Balance

    Time frame: 24 hours

    Amount of net protein gained per unit of time.

Secondary outcomes

  1. Whole Body Protein Synthesis

    Time frame: 24 hours

    Amount of protein produced per unit of time.

  2. 24-hour Mean Glucose

    Time frame: 24 hours

    Derived from continous glucose monitor data.

Other outcomes

  1. Whole Body Protein Breakdown

    Time frame: 24 hours

    Amount of protein broken down per unit of time.

  2. Whole Body Protein Flux

    Time frame: 24 hours

    Amount of protein turnover per unit of time.

  3. Glucose Regulation and Homeostasis

    Time frame: 24 hours

    Derived from continuous glucose monitor data.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Gwin, PA-C

CONTACT

[email protected]

5018380096

David Church, PhD

CONTACT

[email protected]

501-526-5769

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Pork Board

Registry information

Acronym: PORK

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 6, 2023
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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