IGNITE Firefighters' Health

Not Applicable

Not yet recruiting

• Conditions: Microbiome; Immune Function; Cancer; Inflammation

• Registration Number: NCT06567561
• Lead Sponsor: Stanford University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Inclusion Criteria:<br><br> - Age 18+<br><br> - Active SF firefighter<br><br> - Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes,<br> etc.)<br><br> - Willing to complete 4 clinic visits<br><br>Exclusion Criteria:<br><br> - Weight < 110 lb<br><br> - BMI >= 40<br><br> - Self-reported uncontrolled hypercholesterolemia, hypertension or diabetes<br><br> - Pregnant, lactating, or planning to become pregnant during the course of the study.<br><br> - Use of any of the following drugs/supplements within the last 2 months:<br><br> - systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous,<br> intramuscular, or oral);<br><br> - corticosteroids (intravenous, intramuscular, oral, nasal or inhaled);<br><br> - cytokines;<br><br> - methotrexate or immunosuppressive cytotoxic agents.<br><br> - Chronic, clinically significant, or unstable (unresolved, requiring ongoing changes<br> to medical management or medication) pulmonary, cardiovascular, gastrointestinal,<br> hepatic or renal functional abnormality, as determined by medical history, Type 1<br> diabetes, dialysis<br><br> - History of active cancer in the past 3 years except for squamous or basal cell<br> carcinomas of the skin that have been medically managed by local excision<br><br> - Unstable dietary history as defined by major changes in diet during the previous<br> month, where the subject has eliminated or significantly increased a major food<br> group in the diet.<br><br> - Recent history of chronic excessive alcohol consumption defined as more than five<br> 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or<br> five 5-ounce servings of wine per day; or > 14 drinks/week.<br><br> - Any confirmed or suspected condition/state of immunosuppression or immunodeficiency<br> (primary or acquired) including HIV infection, multiple sclerosis, and Graves'<br> disease.<br><br> - Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in<br> the past five years. Any major bowel resection at any time.<br><br> - Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other<br> nicotine-containing products<br><br> - Regular use of prescription opiate pain medication

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in IL-6

Secondary Outcome Measures

Name	Time	Method
Difference in Glyc a;Difference in C-Reactive Protein (CRP);Difference in Interleukin-10 (L-10);Difference in Tumor Necrosis Factor-alpha (TNF-alpha);Difference in Cytokines and Inflammatory Proteins;Difference in Calprotectin;Difference in 8-hydroxy-2'-deoxyguanosine (8-OH-dG);Difference in General DNA Damage;Difference in Superoxide dismutase (SOD);Difference in Catalase;Difference in Glutathione peroxidase (GPx);Difference in Total Glutathione [Glutathione (GSH) + Glutathione disulfide (GSSG)];Difference in Lipid Peroxidation;Difference in F2-isoprostanes;Difference in Protein Carbonyl (protein oxidation);Difference in Total Antioxidant Capacity (TAC);Difference in Fasting Glucose;Difference in Fasting Insulin;Difference in Low-Density-Lipoprotein Cholesterol (LDL);Difference in High-Density-Lipoprotein Cholesterol (HDL);Difference in Triglycerides (TRGs);Difference in Telomeres;Difference in Epigenetic Age;Difference in Gut Microbiome Composition;Difference in Metabolomic Profiles