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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pre Diabetes
• Intervention / Treatment: Other: Lean Pork vs Plant Based

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Church, PhD; Phone Number: 501-526-5769; Email: dchurch@uams.edu
• Study Contact Backup: Name: Amanda Gwin, PA-C; Phone Number: 5018380096; Email: algwin@uams.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Males and females ages 40-60 years. 2. BMI <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. HbA1: 5.7-6.4%

Exclusion Criteria:

• 1. Subject who does not/will not eat animal protein sources. 2. Body mass index <20 kg/m2 or >35 kg/m2. 3. Hemoglobin <10g/dL at screening. 4. Platelets <150,000/uL at screening. 5. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.

  6. History of gastrointestinal bypass/reduction surgery. 7. Pregnant or lactating individuals. 8. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease) 9. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.

  10. Currently using prescription blood thinning medications. 11. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).

  12. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3. 13. Unwilling to avoid using protein or amino-acid supplements during participation.

  14. Unwilling to fast overnight. 15. Unwilling to avoid alcohol, marijuana and CBD products for the four study days.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Quality Protein Intake -Pork; Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from lean pork.	Other: Lean Pork vs Plant Based; Participants will eat pre prepared study meals for three days that have either protein sourced from lean pork or plant sources.
Active Comparator: Low Quality Protein Intake- Plant; Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from plant based protein (ie impossible burger, black bean burger, soy, etc).	Other: Lean Pork vs Plant Based; Participants will eat pre prepared study meals for three days that have either protein sourced from lean pork or plant sources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole Body Protein Balance	Volume of net protein protein produced per unit of time	24 hours

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: The National Pork Board
• Investigators: Principal Investigator: David Church, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: muscle protein synthesis; plant based; protein sources; lean pork
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 276210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No