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

Study Overview
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Brief Summary
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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
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Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults

Conditions
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Pre Diabetes

Intervention / Treatment
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* Other: Lean Pork vs Plant Based


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Quality Protein Intake -Pork<br>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<br>* Participants will eat pre prepared study meals for three days that have either protein sourced from lean pork or plant sources.<br>|
| Active Comparator: Low Quality Protein Intake- Plant<br>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<br>* Participants will eat pre prepared study meals for three days that have either protein sourced from lean pork or plant sources.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plant based, protein sources, lean pork, muscle protein synthesis