IGNITE Firefighters' Health (IGNITE FH)

Stanford University

Status: Enrolling

Conditions: Inflammation; Microbiome; Cancer; Immune Function

Treatments: Behavioral: Usual Firehouse Diet; Behavioral: Whole Foods Plant-Based Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06567561

75777

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Whole Food Plant-Based Diet

Experimental group

Description:

Participants will be asked to consume and predominantly vegan, whole-foods diet, with the addition of fish, eggs, and fermented dairy.

Treatment:

Behavioral: Whole Foods Plant-Based Diet

Usual Firehouse Diet

Active Comparator group

Description:

Participants will be asked to consume their usual firehouse meals.

Treatment:

Behavioral: Usual Firehouse Diet