What side effects are associated with this type of intervention?

Common dietary interventions for inflammation include the consumption of specific types of meat and plant-based alternatives. For example, grain-fed beef, grass-fed beef, and plant-based meat alternatives like the Impossible Burger are being studied for their effects on inflammation. Potential side effects of high meat consumption, particularly red and processed meats, include increased risk of cardiovascular disease, certain cancers, and metabolic issues such as obesity and type 2 diabetes. Plant-based alternatives may have fewer adverse effects but can sometimes cause digestive issues due to high fiber content. It is important to balance these dietary choices with overall nutritional needs and health goals.

What prior FDA approvals exist?

The FDA has approved several treatments for inflammation, particularly those targeting inflammatory pathways. Notable examples include TNF-alpha inhibitors like infliximab and adalimumab, which are used to treat conditions such as rheumatoid arthritis and Crohn's disease. These biologic agents work by blocking the tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. Additionally, IL-12/23 inhibitors like ustekinumab have been approved for treating psoriasis and psoriatic arthritis by targeting specific interleukins involved in the inflammatory process. While these treatments are not directly related to dietary inflammation, they provide insight into the mechanisms that could be influenced by different types of meat consumption as studied in the trial.

What other types of research exist?

Promising alternatives to meat consumption for inflammation patients include plant-based meat alternatives, such as the Impossible Burger, which have been shown to impact inflammatory markers and metabolite profiles. Additionally, diets rich in polyunsaturated fatty acids (PUFAs), particularly n-6 PUFAs, have been associated with reduced chronic systemic inflammation. The Dietary Approaches to Stop Hypertension (DASH) diet and the Mediterranean diet are also effective in managing inflammation due to their emphasis on fruits, vegetables, whole grains, and healthy fats.

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Beef

Burger Types for Inflammation

N/A

Waitlist Available

Led By Stephan van Vliet, PhD

Research Sponsored by Utah State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately before meal

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There are no direct side effects from eating the burgers mentioned in the study; however, participants may experience discomfort from frequent blood draws such as bruising at the needle site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from fasting concentrations after eating.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from fasting concentrations after eating.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from fasting concentrations after eating. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inflammatory cytokine biomarker (C-reactive protein) concentrations in plasma samples

Inflammatory cytokine biomarker (IL-6) concentrations in plasma samples

Inflammatory cytokine biomarker (TNF-alpha) concentrations in plasma samples

+2 more

Secondary study objectives

Mood Questionnaires

Satiety Questionnaire

Taste Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Active Control

Group I: Sequence 6: Grass-Fed, Impossible, Grain-FedActive Control3 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-FedActive Control3 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-FedActive Control3 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-FedActive Control3 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, ImpossibleActive Control3 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, ImpossibleActive Control3 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for inflammation often target the reduction of inflammatory markers and the modulation of metabolite profiles in the blood. Dietary interventions, such as the consumption of different types of meat (grain-fed beef, grass-fed beef) and plant-based alternatives (Impossible Burger), can influence these markers. For instance, grass-fed beef may have a different fatty acid profile compared to grain-fed beef, potentially leading to lower levels of pro-inflammatory markers. Plant-based alternatives might offer benefits through higher levels of phenolics and other anti-inflammatory compounds. These dietary choices matter for inflammation patients as they can modulate the body's inflammatory response, potentially reducing chronic inflammation and associated risks of diseases such as cardiovascular conditions and metabolic disorders.