Hyperglycaemia (Non Diabetic)PORKNCT06025292
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
A study testing Lean Pork vs Plant-Based Protein in people with Hyperglycaemia (Non Diabetic) and Prediabetes, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hyperglycaemia (Non Diabetic), Prediabetes
- What is being tested?
- Lean Pork vs Plant-Based Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Males and females ages 40-65 years.
- 2. BMI 25 to ≤40 kg/m2 (or body fat % ≥25% in males or ≥36% in females)
- 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. HbA1c: 5.7-6.4% or fasting glucose 100-125 mg/dL
Who cannot join
- 1. Participant who does not/will not eat animal protein sources.
- 2. Allergy to wheat, soy, or common ingredients in plant-based protein products.
- 3. Body mass index <25 kg/m2 or >40 kg/m2.
- 4. Hemoglobin <10g/dL at screening.
- 5. Platelets <150,000/uL at screening.
- 6. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
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- 7. History of gastrointestinal bypass/reduction surgery.
- 8. Pregnant or lactating individuals.
- 9. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
- 10. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- 11. Currently using prescription blood thinning medications.
- 12. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
- 13. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3 and Visit 7.
- 14. Unwilling to avoid using protein or amino-acid supplements during participation.
- 15. Unwilling to fast overnight.
- 16. Unwilling to avoid alcohol, marijuana and CBD products for the four study days.
- 17. Participants on glucagon-like-peptide-1 receptor agonist (GLP-1-RA) medications for <1 month or with less than one treatment dose (injection) every two weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
David D Church, PhD, dchurch@uams.edu
About this study
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.
- Conditions
- Hyperglycaemia (Non Diabetic), Prediabetes
- Being tested
- Lean Pork vs Plant-Based Protein
- Keywords
- Lean pork, Muscle Protein Synthesis, Protein, Plant-Based
- Medical subject headings
- Hyperglycemia, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lean Pork vs Plant-Based ProteinOther
Participants will eat prepared study meals for three days that have either protein sourced from lean pork or plant-based sources.
| Study group | Role | What they receive |
|---|---|---|
| High Quality Protein Intake - Lean Pork | Active comparator | 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. Receives: Other: Lean Pork vs Plant-Based Protein |
| Low Quality Protein Intake - Plant-Based | Active comparator | 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). Receives: Other: Lean Pork vs Plant-Based Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Protein Synthesis
Mixed muscle protein synthesis expressed as the fractional synthetic rate.
Measured: 24 hours
Whole Body Protein Balance
Amount of net protein gained per unit of time.
Measured: 24 hours
Secondary outcomes (2)
Whole Body Protein Synthesis
Amount of protein produced per unit of time.
Measured: 24 hours
24-hour Mean Glucose
Derived from continous glucose monitor data.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start11 Sep 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycaemia (Non Diabetic)Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Pork Board
- Responsible party
- Sponsor
- Investigators
- David Church, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025292
- Sponsor's protocol ID
- 276210
- Acronym
- PORK
- Status last verified
- Nov 2026
- First submitted
- 29 Aug 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
- ClinicalTrials.gov ID
- NCT06025292
- Acronym / sponsor ID
- PORK / 276210
- Conditions
- Hyperglycaemia (Non Diabetic), Prediabetes
- Keywords
- Lean pork, Muscle Protein Synthesis, Protein, Plant-Based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Pork Board
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Quality Protein Intake - Lean Pork | Active comparator | Other: Lean Pork vs Plant-Based ProteinMeal 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. |
| Low Quality Protein Intake - Plant-Based | Active comparator | Other: Lean Pork vs Plant-Based ProteinMeal 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). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Males and females ages 40-65 years.
- 2. BMI 25 to ≤40 kg/m2 (or body fat % ≥25% in males or ≥36% in females)
- 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
Key exclusion criteria (17 listed)
- 1. Participant who does not/will not eat animal protein sources.
- 2. Allergy to wheat, soy, or common ingredients in plant-based protein products.
- 3. Body mass index <25 kg/m2 or >40 kg/m2.
- 4. Hemoglobin <10g/dL at screening.
- 5. Platelets <150,000/uL at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lean Pork vs Plant-Based ProteinParticipants will eat prepared study meals for three days that have either protein sourced from lean pork or plant-based sources. | Other | High Quality Protein Intake - Lean Pork, Low Quality Protein Intake - Plant-Based |
Primary outcome
Muscle Protein Synthesis
Time frame: 24 hours
Mixed muscle protein synthesis expressed as the fractional synthetic rate.
Whole Body Protein Balance
Time frame: 24 hours
Amount of net protein gained per unit of time.
2 secondary outcomes
Whole Body Protein Synthesis
Time frame: 24 hours
24-hour Mean Glucose
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Church, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lean Pork vs Plant-Based Protein in people with Hyperglycaemia (Non Diabetic) and Prediabetes, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Church, PhD (501-526-5769, dchurch@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Protein Synthesis (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.