Burger Types for Inflammation

Overseen By Travis E Statham, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Utah State University

Must not be taking: NSAIDs, Corticosteroids, Anticoagulants, others

Disqualifiers: Diabetes, Inflammatory diseases, Malignancy, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of burgers affect inflammation and other compounds in the blood of middle-aged individuals. Participants will try grain-fed beef, grass-fed beef, and plant-based burgers on separate visits. The goal is to determine which type of burger has the least impact on inflammation. Individuals who are overweight or obese and have maintained a stable weight for 3 months might be a good fit.

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

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that could affect the study's results, like NSAIDs (non-steroidal anti-inflammatory drugs) and corticosteroids, or those that increase risk, like anticoagulants, if they cannot be temporarily stopped for the study.

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

Research shows that different types of beef and plant-based burgers have varying safety levels. For grain-fed beef, no clear proof exists that it is safer than grass-fed beef. One study found both types had similar bacteria levels. An older study found that 18% of grain-fed beef samples contained "superbugs," bacteria resistant to antibiotics.

Grass-fed beef has not been proven healthier than grain-fed beef, but it typically contains less fat and fewer calories. Studies have not shown that eating red meat directly causes inflammation, which involves swelling and pain in the body.

For the Impossible Burger, findings are mixed. The FDA has reviewed its main ingredient several times and deemed it safe to eat. However, some reports suggest possible risks, such as changes in weight gain and signs of inflammation. Concerns also exist that one ingredient, SLH, might cause allergies since people have not traditionally consumed it.

These findings present a mixed view of the safety of these burger types. Participants should consider these factors and their health conditions when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Burger Types for Inflammation trial because it could reveal how different types of burgers affect inflammation in the body. Unlike current options that primarily focus on medication to manage inflammation, this trial explores dietary impacts, which could offer a more natural approach. By comparing grain-fed beef, grass-fed beef, and plant-based (Impossible Burger™) options, researchers aim to identify if any of these burger types can reduce inflammation more effectively or offer healthier alternatives. This could lead to a better understanding of how dietary choices impact inflammation, potentially shifting future recommendations for managing inflammatory conditions.

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

This trial will compare the effects of different burger types on inflammation. Research has shown that grass-fed beef, which participants in some sequences of this trial will consume, contains healthier fats and more antioxidants than grain-fed beef, potentially reducing inflammation. Other sequences will include the Impossible Burger, a plant-based option. Studies find that diets rich in plant-based foods often link to lower inflammation, although some research suggests that switching to plant-based meats doesn't always improve inflammation. Each type of burger in this trial may affect inflammation differently, but evidence suggests possible benefits from both grass-fed beef and plant-based options. ^{2 4 6 7 8}

Who Is on the Research Team?

Stephan van Vliet, PhD

Principal Investigator

Utah State University

Are You a Good Fit for This Trial?

This trial is for overweight or obese adults aged 30-60 who have been weight stable in the past 3 months. Participants must not be heavy drinkers, pregnant, lactating, allergic to soy, smokers, or have certain health conditions like diabetes or heart failure. They should not be on medications affecting inflammation and can't have had a recent COVID vaccine.

Inclusion Criteria

BMI must be between 25 and 35 kg/m2

Weight must be stable in the last 3 months (Loss or gain <4%)

Hemoglobin A1C (HbA1C) must be ≤6.4%

Exclusion Criteria

Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits

Consuming more than 14 drinks per week

Use of cigarettes (or other tobacco products) in the last 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person or virtual)

Metabolic Testing

Participants consume different types of meat and plant-based alternatives, with blood and urine samples collected to assess inflammatory and metabolic responses.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Grain-Fed Beef Hamburger
• Grass-Fed Beef Hamburger
• Impossible BurgerTM

Trial Overview The study compares the effects of consuming a grain-fed beef hamburger, grass-fed beef hamburger, or an Impossible Burger on blood markers of inflammation and metabolism. Each participant will eat each type of burger on separate visits with blood samples taken before and after meals at specific intervals.

How Is the Trial Designed?

Group I: Sequence 6: Grass-Fed, Impossible, Grain-Fed Active Control 3 Interventions

On the first visit, a grass-fed beef burger (250 grams) will be consumed. On the second visit, an Impossible BurgerTM (250 grams) will be consumed. On the third visit, a grain-fed beef burger (250 grams) will be consumed.

Group II: Sequence 5: Grain-Fed, Impossible, Grass-Fed Active Control 3 Interventions

On the first visit, a grain-fed beef burger (250 grams) will be consumed. On the second visit, an Impossible BurgerTM (250 grams) will be consumed. On the third visit, a grass-fed beef burger (250 grams) will be consumed.

Group III: Sequence 3: Impossible, Grass-Fed, Grain-Fed Active Control 3 Interventions

On the first visit, an Impossible BurgerTM (250 grams) will be consumed. On the second visit, a grass-fed beef burger (250 grams) will be consumed. On the third visit, a grain-fed beef burger (250 grams) will be consumed.

Group IV: Sequence 4: Impossible, Grain-Fed, Grass-Fed Active Control 3 Interventions

On the first visit, an Impossible BurgerTM (250 grams) will be consumed. On the second visit, a grain-fed beef burger (250 grams) will be consumed. On the third visit, a grass-fed beef burger (250 grams) will be consumed.

Group V: Sequence 1: Grain-Fed, Grass-Fed, Impossible Active Control 3 Interventions

On the first visit, a grain-fed beef burger (250 grams) will be consumed. On the second visit, a grass-fed beef burger (250 grams) will be consumed. On the third visit, an Impossible BurgerTM (250 grams) will be consumed.

Group VI: Sequence 2: Grass-Fed, Grain-Fed, Impossible Active Control 3 Interventions

On the first visit, a grass-fed beef burger (250 grams) will be consumed. On the second visit, a grain-fed beef burger (250 grams) will be consumed. On the third visit, an Impossible BurgerTM (250 grams) will be consumed.

Who Is Running the Clinical Trial?

Utah State University

Lead Sponsor

Trials

48

Recruited

5,200+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2846864/

A review of fatty acid profiles and antioxidant content in grass ... Research spanning three decades suggests that grass-based diets can significantly improve the fatty acid (FA) composition and antioxidant content of beef.

2. withpower.com withpower.com/trial/phase-inflammatory-responses-1-2023-0cbf7

Burger Types for Inflammation · Info for Participants This trial studies how different types of meat (regular beef, grass-fed beef, plant-based burger) affect inflammation and health markers in overweight or obese ...

3. researchgate.net researchgate.net/publication/395216330_Postprandial_amino_acids_and_health_markers_from_organic_grass-fed_and_conventional_beef_in_healthy_participants_-_a_pilot_randomized_clinical_trial

Postprandial amino acids and health markers from organic ... This study investigates the impact of organic grass-fed (GRA) versus conventional (CON) cattle-feeding systems on human postprandial ...

4. frontiersin.org frontiersin.org/journals/sustainable-food-systems/articles/10.3389/fsufs.2020.555426/full

Health-Promoting Phytonutrients Are Higher in Grass-Fed ... Only a handful of studies have investigated the effects of grass-fed meat and dairy consumption on human health and show potential for anti-inflammatory effects ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8754571/

Higher Meat Intake Is Associated with Higher Inflammatory ... Higher meat consumption, particularly of processed meat, was positively associated with inflammatory markers in these British adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8728510/

Fatty Acid Composition of Grain- and Grass-Fed Beef ... Grass-fed beef showed greater levels of trans-vaccenic acid and long-chain n-3 polyunsaturated fatty acids (PUFA; EPA, DPA, DHA) than grain-fed beef.

7. cidrap.umn.edu cidrap.umn.edu/antimicrobial-stewardship/study-finds-no-clear-safety-advantage-grass-fed-beef

Study finds no clear safety advantage for grass-fed beef A recent study of a modest sample of US retail beef products found little difference between the levels of bacteria in grass-fed and conventionally raised beef.

8. webmd.com webmd.com/diet/grass-fed-beef-good-for-you

Grass-Fed Beef: Is It Good for You? But a 2015 study that tested 300 packages of ground beef found that 18% of the grain-fed samples contained "superbugs" -- bacteria that are ...