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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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 middle-aged adults. Blood samples are taken to measure these effects.

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.

What data supports the effectiveness of the treatment Burger Types for Inflammation?

Research suggests that plant-based diets, like those including the Impossible Burger, are linked to lower levels of inflammation markers compared to diets high in red meat, which may help reduce inflammation. ^{1 2 3 4 5}

How does the treatment of different burger types for inflammation differ from other treatments?

This study is unique as it compares the inflammatory effects of different types of burgers, including grain-fed, grass-fed, and plant-based options, which is not a standard approach for treating inflammation. Unlike traditional anti-inflammatory treatments, this trial focuses on dietary choices and their impact on inflammation markers. ^{1 3 5 6 7}

Research Team

Stephan van Vliet, PhD

Principal Investigator

Utah State University

Eligibility Criteria

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

I am between 30 and 60 years old.

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

I am not on medications that could interfere with the study.

I have a history of inflammatory diseases like arthritis or hepatitis.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Plasma Inflammation Markers of the Tumor Necrosis Factor Pathway but Not C-Reactive Protein Are Associated with Processed Meat and Unprocessed Red Meat Consumption in Bavarian Adults. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Anti-Inflammatory Nutrients and Obesity-Associated Metabolic-Inflammation: State of the Art and Future Direction. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Higher Meat Intake Is Associated with Higher Inflammatory Markers, Mostly Due to Adiposity: Results from UK Biobank. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Vegetarian-Based Dietary Patterns and their Relation with Inflammatory and Immune Biomarkers: A Systematic Review and Meta-Analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Differences in postprandial inflammatory responses to a 'modern' v. traditional meat meal: a preliminary study. [2010]

6. England pubmed.ncbi.nlm.nih.gov

Hass avocado modulates postprandial vascular reactivity and postprandial inflammatory responses to a hamburger meal in healthy volunteers. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Antioxidant-rich spice added to hamburger meat during cooking results in reduced meat, plasma, and urine malondialdehyde concentrations. [2023]