Lean Pork vs Plant-Based Diets for Prediabetes

(PORK Trial)

Recruiting at 1 trial location

Overseen By Amanda Gwin, PA-C

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Must not be taking: Blood thinners, Corticosteroids, Androgens, Anabolics

Disqualifiers: Animal protein abstinence, Cancer history, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effects of lean pork and plant-based diets on protein and glucose levels in people with prediabetes. Participants will follow meal plans resembling a typical American diet, with one group consuming lean pork as their protein source and the other group consuming plant-based proteins like soy or black bean burgers. The study seeks individuals who are prediabetic, have a BMI between 25 and 40, and are willing to avoid alcohol and certain supplements during the study.

As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on prediabetes.

Will I have to stop taking my current medications?

The trial requires you to stop using certain medications, such as prescription blood thinners, corticosteroids, and aspirin (for 7 days before a specific visit). If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that regularly eating lean pork is generally safe for most people. Studies suggest it might even help reduce body fat without causing major issues. In contrast, plant-based diets are also safe and offer several health benefits. They can improve the body's ability to use sugar and might lower the risk of diseases like type 2 diabetes. Both eating lean pork and following plant-based diets appear to be well-tolerated, with few reported problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about examining dietary approaches for prediabetes, specifically comparing lean pork and plant-based diets, because these treatments offer a unique angle on managing the condition. While traditional management often focuses on medications like metformin or lifestyle changes involving general diet and exercise, this study targets specific protein sources. Lean pork provides a high-quality animal protein that may impact insulin sensitivity differently than plant-based proteins like soy or black bean burgers. Exploring these distinct protein sources could reveal new insights into how specific dietary choices influence prediabetes, potentially offering more tailored dietary recommendations for individuals at risk.

What evidence suggests that this trial's treatments could be effective for prediabetes?

This trial will compare the effects of a diet high in lean pork with a plant-based diet for individuals with prediabetes. Research has shown that a plant-based diet can lower the risk of developing insulin resistance and type 2 diabetes. These diets improve insulin use and reduce cellular stress in people with diabetes. For those who are overweight, plant-based diets can aid in weight loss, reduce body fat, and enhance insulin management more effectively than regular diets.

Conversely, lean pork, which participants in one arm of this trial will consume, can also contribute to a healthy diet. Some studies suggest that eating lean pork might help maintain muscle while losing fat. However, evidence about its direct effects on insulin resistance is less clear compared to plant-based diets. Overall, both diets offer benefits, but plant-based diets have stronger evidence for improving insulin-related health. ^{1 2 3 4 6}

Who Is on the Research Team?

David Church, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for men and women aged 40-60 with a BMI under 35, who are prediabetic (HbA1c levels between 5.7% to 6.4%). Participants must be able to consent, not have COVID-19 symptoms or a positive test, and agree not to consume alcohol, marijuana, or CBD during the study.

Inclusion Criteria

BMI <35 kg/m2

Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 4-day study meal period

I am between 40 and 60 years old.

Exclusion Criteria

I am currently taking prescribed blood thinners.

I cannot or will not stop taking aspirin for 7 days before my third visit.

Unwilling to avoid using protein or amino-acid supplements during participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants follow a high-quality protein diet composed primarily of lean pork loin or a lower-quality plant-based protein diet

4 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after dietary intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lean Pork vs Plant Based

Trial Overview

The study compares two diets in prediabetic adults: one high in lean pork loin protein (PORK) and another based on lower-quality plant proteins (PLANT). It will assess their effects on muscle/protein turnover and blood sugar control.

How Is the Trial Designed?

Group I: High Quality Protein Intake - Lean Pork Active Control 1 Intervention

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.

Group II: Low Quality Protein Intake - Plant-Based Active Control 1 Intervention

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).

Lean Pork vs Plant Based is already approved in United States, European Union for the following indications:

Approved in United States as Pork for:

• General nutrition
• Protein supplementation

Approved in European Union as Pork for:

• General nutrition
• Protein supplementation

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

National Pork Board

Collaborator

Trials

6

Recruited

390+

The National Pork Board

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a 6-month study involving 164 overweight adults, those who incorporated up to 1 kg of lean pork per week showed significant reductions in weight, BMI, waist circumference, and body fat compared to a control group.

The weight loss observed in the pork group was primarily due to a decrease in fat mass, with no adverse effects on lean mass or other metabolic parameters, suggesting that lean pork can be a beneficial addition to a weight loss diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of eating fresh lean pork on cardiometabolic health parameters. Murphy, KJ., Thomson, RL., Coates, AM., et al.[2021]

A higher adherence to a plant-based diet is linked to lower insulin resistance and reduced risk of developing prediabetes and type 2 diabetes (T2D), based on a study of 6798 participants over a median follow-up of 5.7 to 7.3 years.

Specifically, for every 10-point increase in the plant-based dietary index, insulin resistance decreased and the risk of T2D was reduced by 13%, supporting the idea that a more plant-based diet can be beneficial for metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant versus animal based diets and insulin resistance, prediabetes and type 2 diabetes: the Rotterdam Study. Chen, Z., Zuurmond, MG., van der Schaft, N., et al.[2021]

In a study of 8041 middle-aged adults over a median follow-up of 13 years, adherence to plant-based diet indices (oPDI, hPDI, and provegetarian diet) was linked to a 12-16% lower risk of developing hypertension, indicating their potential protective effect against this condition.

Conversely, higher adherence to the unhealthy PDI (uPDI) was associated with a 13% increased risk of hypertension, highlighting the importance of diet quality in managing health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operational Differences in Plant-Based Diet Indices Affect the Ability to Detect Associations with Incident Hypertension in Middle-Aged US Adults. Kim, H., Rebholz, CM., Garcia-Larsen, V., et al.[2023]

In a study with 240 growing-finishing pigs, those given a choice between low- and high-lysine diets did not optimize their lysine intake for better growth and carcass leanness, as their intake exceeded the necessary amounts.

The results indicated that while pigs could select diets, the choice treatments led to less desirable outcomes in terms of lean percentage and feed efficiency compared to a controlled diet with specific lysine levels, suggesting that this approach is not practical for commercial swine production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-selection of diets and lysine requirements of growing-finishing swine. Owen, KQ., Knabe, DA., Burgoon, KG., et al.[2019]

A plant-based eating pattern, which includes whole grains, vegetables, fruits, and legumes while excluding animal products, is linked to a lower risk of developing type 2 diabetes and is effective in managing the condition.

This diet improves key health markers such as blood glucose levels, body weight, and blood pressure, and it also enhances insulin sensitivity and β-cell function, which are crucial for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations. Jardine, MA., Kahleova, H., Levin, SM., et al.[2023]

Plant-based dietary patterns (PBDs) significantly reduce body weight, BMI, and waist circumference in individuals with type 2 diabetes compared to regular meat-eating diets, with an average weight loss of 2.35 kg and a BMI reduction of 0.90 kg/m² based on a meta-analysis of 7 trials involving 269 participants.

PBDs alone can lead to a substantial weight loss of 5.1% and a decrease in waist circumference by 4.3%, indicating their effectiveness in managing obesity-related risks in type 2 diabetes without necessarily limiting energy intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Plant-Based Diets on Weight Status in Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Austin, G., Ferguson, JJA., Garg, ML.[2023]

In a nine-month study involving 49 overweight or obese adults, regular consumption of pork, beef, or chicken did not lead to significant differences in body mass index (BMI) or other markers of body fat.

The findings suggest that diets high in pork protein do not provide unique benefits for body composition compared to other high-protein meats like beef and chicken, indicating that the type of meat may not significantly impact adiposity in overweight individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of regular consumption of fresh lean pork, beef and chicken on body composition: a randomized cross-over trial. Murphy, KJ., Parker, B., Dyer, KA., et al.[2022]

A systematic review of eight studies found that pork intake does not significantly differ from other protein sources like beef and shrimp in terms of glucose-insulin response, but processed pork (ham) may lead to a larger insulin response compared to eggs.

Longer interventions (11 days to 6 months) showed no significant impact of pork on metabolic syndrome components, although one study suggested potential benefits on waist circumference and HDL cholesterol, highlighting the need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of clinical studies related to pork intake and metabolic syndrome or its components. Stettler, N., Murphy, MM., Barraj, LM., et al.[2021]

Replacing animal protein with plant protein in the diet can lead to modest improvements in glycemic control for individuals with diabetes, as shown by significant reductions in HbA1c, fasting glucose, and fasting insulin levels across 13 randomized controlled trials involving 280 participants.

The study suggests that a median replacement of about 35% of total protein with plant sources is effective, but highlights the need for larger and higher-quality trials to confirm these findings and address uncertainties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Replacing Animal Protein with Plant Protein on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Viguiliouk, E., Stewart, SE., Jayalath, VH., et al.[2023]

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