IGNITE Firefighters' Health

Trial Title: IGNITE Firefighters' Health

NCT ID: NCT06567561

Condition: Cancer
Inflammation
Microbiome
Immune Function

Conditions: Official terms:
Inflammation

Conditions: Keywords:
Cancer
Inflammation
Microbiome
Immune function

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Whole Foods Plant-Based Diet
Description: Whole foods, predominantly plant-based diet, with the addition of fish, eggs, and fermented dairy.
Arm group label: Whole Food Plant-Based Diet

Intervention type: Behavioral
Intervention name: Usual Firehouse Diet
Description: Usual firehouse meals.
Arm group label: Usual Firehouse Diet

Summary: Investigators hope to learn about potential dietary intervention strategies (specifically a whole-food, plant-based diet) that may help lower cancer markers in firefighters.

Detailed description: The purpose of the San Francisco (SF) Firefighter's Diet Study is to determine if a diet low in processed foods, mostly plant-based, with added fermented foods, can lower the risk of cancer in firefighters. We will assess this by randomly assigning SF firefighters to either a whole-food, plant-based diet or their usual firehouse meals. Participants will be followed for 12 weeks.

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: December 16, 2024

Completion date: December 16, 2025

Lead sponsor:
Agency: Stanford University
Agency class: Other

Source: Stanford University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06567561
https://med.stanford.edu/nutrition/research/current-studies/ignite-firefighters--health.html