Comparing lean pork and plant-based protein diets for prediabetic adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effects of a high-quality protein diet primarily consisting of lean pork loin against a lower-quality plant-based protein diet in adults with prediabetes. It aims to assess how these dietary interventions influence muscle protein synthesis, whole-body protein turnover, and glucose regulation. Participants will be monitored over a four-day meal period while adhering to specific dietary restrictions. The study focuses on understanding the role of protein quality in managing prediabetes.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting

Study contacts

• Principal investigator: David Church, PhD — University of Arkansas
• Study coordinator: David Church, PhD
• Email: dchurch@uams.edu
• Phone: 501-526-5769

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.