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

Sponsor

University of Arkansas (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06025292

Collaborator

The National Pork Board (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pre Diabetes	Other: Lean Pork vs Plant Based	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Whole Body Protein Balance [24 hours]
Volume of net protein protein produced per unit of time

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

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.
Currently using prescription blood thinning medications. 11. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
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.
Unwilling to fast overnight. 15. Unwilling to avoid alcohol, marijuana and CBD products for the four study days.
Participating in >200 minutes/week of vigorous exercise and/or >4 days/week of resistance training.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Arkansas
The National Pork Board

Investigators

Principal Investigator: David Church, PhD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT06025292

Other Study ID Numbers:

276210

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 6, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Arkansas

plant based

protein sources

lean pork

muscle protein synthesis

Additional relevant MeSH terms:

Prediabetic State

Study Results

No Results Posted as of Sep 6, 2023