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

Primary Purpose

Pre Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lean Pork vs Plant Based
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pre Diabetes focused on measuring plant based, protein sources, lean pork, muscle protein synthesis

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    High Quality Protein Intake -Pork

    Low Quality Protein Intake- Plant

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    Whole Body Protein Balance
    Volume of net protein protein produced per unit of time

    Secondary Outcome Measures

    Full Information

    First Posted
    August 29, 2023
    Last Updated
    August 29, 2023
    Sponsor
    University of Arkansas
    Collaborators
    The National Pork Board
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06025292
    Brief Title
    Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
    Acronym
    PORK
    Official Title
    Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2025 (Anticipated)
    Study Completion Date
    June 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arkansas
    Collaborators
    The National Pork Board

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pre Diabetes
    Keywords
    plant based, protein sources, lean pork, muscle protein synthesis

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High Quality Protein Intake -Pork
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Low Quality Protein Intake- Plant
    Arm Type
    Active Comparator
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Lean Pork vs Plant Based
    Intervention Description
    Participants will eat pre prepared study meals for three days that have either protein sourced from lean pork or plant sources.
    Primary Outcome Measure Information:
    Title
    Whole Body Protein Balance
    Description
    Volume of net protein protein produced per unit of time
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David Church, PhD
    Phone
    501-526-5769
    Email
    dchurch@uams.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amanda Gwin, PA-C
    Phone
    5018380096
    Email
    algwin@uams.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Church, PhD
    Organizational Affiliation
    University of Arkansas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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