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

Pre Diabetes Clinical Trial

— PORK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06025292
• Other study ID #: 276210
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: August 2023
• Source: University of Arkansas
• Contact: David Church, PhD
• Phone: 501-526-5769
• Email: dchurch[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre Diabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Pork Board

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole Body Protein Balance	Volume of net protein protein produced per unit of time	24 hours