Comparing lean pork and plant-based protein diets for prediabetic adults
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
This study tests whether eating lean pork or plant-based protein helps adults with prediabetes manage their blood sugar and build muscle better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | University of Arkansas Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT06025292 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 40-60 years with a BMI between 25 and 40 and an HbA1c level between 5.7 and 6.4%.
Not a fit: Patients who do not consume animal protein or have certain health conditions, such as chronic inflammatory diseases or recent cancer treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary recommendations that improve glucose regulation and protein metabolism in prediabetic individuals.
How similar studies have performed: While there is ongoing research into protein quality and its effects on health, this specific comparison of lean pork versus plant-based protein in prediabetic adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Little Rock, Arkansas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.