RECRUITING

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

Conditions

Hyperglycaemia (Non Diabetic)Prediabetes Lean pork Muscle Protein Synthesis Protein Plant-Based

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-11

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06025292

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 1. Males and females ages 40-60 years. * 2. BMI 25 to \<35 kg/m2. * 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%	* 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 \>35 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. * 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. Participating in \>200 minutes/week of vigorous exercise and/or \>4 days/week of resistance training.

Inclusion Criteria

Exclusion Criteria

* 1. Males and females ages 40-60 years.
* 2. BMI 25 to \<35 kg/m2.
* 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%

* 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 \>35 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.
* 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. Participating in \>200 minutes/week of vigorous exercise and/or \>4 days/week of resistance training.

Contacts and Locations

Study Contact

David Church, PhD

CONTACT

501-526-5769

dchurch@uams.edu

Amanda Gwin, PA-C

CONTACT

5018380096

algwin@uams.edu

Principal Investigator

David Church, PhD

PRINCIPAL_INVESTIGATOR

University of Arkansas

Study Locations (Sites)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Collaborators and Investigators

Sponsor: University of Arkansas

David Church, PhD, PRINCIPAL_INVESTIGATOR, University of Arkansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2024-09-11

Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

Lean pork
Muscle Protein Synthesis
Protein
Plant-Based

Additional Relevant MeSH Terms

Hyperglycaemia (Non Diabetic)
Prediabetes