What side effects are associated with this type of intervention?

Common treatments for inflammation include TNF-alpha inhibitors, methotrexate, and biologic agents. TNF-alpha inhibitors can reduce the risk of myocardial infarction but may cause infections and injection site reactions. Methotrexate is effective but can lead to liver toxicity, bone marrow suppression, and gastrointestinal issues. Biologic agents, while reducing cardiovascular events, may increase the risk of infections and potential allergic reactions. These treatments are generally well-tolerated but require monitoring for adverse effects.

What prior FDA approvals exist?

The FDA has approved several biologic agents and anti-inflammatory drugs for the treatment of inflammation. Notable examples include TNF-alpha inhibitors like etanercept and adalimumab, which are used to treat conditions such as rheumatoid arthritis and psoriasis. Ustekinumab, an IL-12/23 inhibitor, is another biologic approved for treating psoriatic arthritis and plaque psoriasis. These treatments aim to reduce inflammation and improve clinical outcomes in patients with chronic inflammatory diseases. While the trial on the consumption of foods from agro-ecological systems focuses on dietary interventions, the underlying goal of reducing inflammation aligns with the mechanisms of these FDA-approved biologics.

What other types of research exist?

Promising alternatives include: 1) Anti-inflammatory diets such as the Mediterranean diet, which is rich in fruits, vegetables, whole grains, and healthy fats. 2) Omega-3 fatty acid supplements, commonly found in fish oil, which have been shown to reduce inflammation. 3) Plant-based diets, including vegetarian and vegan diets, which are associated with lower levels of inflammatory markers. 4) Polyphenol-rich foods like berries, nuts, and green tea, which have antioxidant and anti-inflammatory properties. 5) Probiotics and prebiotics, which can improve gut health and reduce systemic inflammation.

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Agro-Ecological vs Conventional Diet for Inflammation (AGROHEALTH Trial)

N/A

Waitlist Available

Led By Stephan van Vliet

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 day 44 (post)

Awards & highlights

No Placebo-Only Group

Summary

This trial compares the health effects of eating foods from eco-friendly farms versus regular farms in middle-aged adults. Researchers will look at changes in inflammation and metabolism by analyzing blood, urine, and stool samples. The goal is to see if the eco-friendly diet offers better health benefits.

Who is the study for?

This trial is for adults aged 35-60 with a BMI between 25 and 35, stable weight and medication use, non-diabetic blood glucose levels, not pregnant or planning to be, moderate alcohol consumption, non-smokers. Excludes those with inflammatory diseases, on certain medications like NSAIDs or steroids, engaged in high-level exercise or following strict diets.

What is being tested?

The study compares the health effects of two diets over a period of 44 days: one diet uses conventionally sourced foods (YELLOW Diet), while the other uses foods from agro-ecological farming (GREEN Diet). Both diets are matched for macronutrients and food sources to assess their impact on inflammation and metabolic health markers.

What are the potential side effects?

Since this trial involves dietary changes rather than medication or medical procedures, side effects may include digestive discomfort as participants adjust to new eating patterns. However specific side effects will depend on individual reactions to different food sources.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 44 (post)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 44 (post)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 44 (post) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composition of gut microbiota bacteria using 16s rRNA sequencing

C-reactive protein

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

+1 more

Secondary study objectives

Pittsburgh Sleep Quality Index (PSQI) scores

Profile of Mood States (POMS) scores

Short Form Healthy Survey (SF-36) scores

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Sequence 2: Conventional (Yellow) - Agro (Green)Active Control2 Interventions

First, the conventional sourced diet will be consumed. Secondly, the agro-ecological sourced diet will be consumed.

Group II: Sequence 1: Agro (Green) - Conventional (Yellow)Active Control2 Interventions

First, the agro-ecological sourced diet will be consumed. Secondly, the conventional sourced diet will be consumed.

Do I qualify?Apply below to find out

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 include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and biologics such as TNF-alpha inhibitors. NSAIDs work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), reducing the production of prostaglandins that cause inflammation and pain. Corticosteroids suppress the immune system by decreasing the production of inflammatory chemicals and reducing the activity of immune cells. TNF-alpha inhibitors block the action of tumor necrosis factor-alpha, a cytokine involved in systemic inflammation. For inflammation patients, understanding these mechanisms is crucial as it highlights the importance of targeting specific pathways to reduce inflammation effectively. Additionally, dietary interventions, such as consuming foods from agro-ecological systems, may offer complementary benefits by potentially improving inflammatory biomarkers, thus providing a holistic approach to managing inflammation.