Implementing Good Nutrition to Improve, Transform, and Enhance (IGNITE) Firefighters' Health

NCT06567561 | Completed DMC

• 2 other identifiers: IRB-75777NCI-2025-01830
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Microbiome; Immune Function; Cancer

Keywords

Cancer; Inflammation; Microbiome; Immune function

Outcome Measures

Primary Outcomes (1)

• Difference in IL-6

  Difference in the 8-week change from baseline in IL-6 between the whole-food plant-based vs. usual diet groups.

  Baseline and 8 weeks

Secondary Outcomes (23)

• Difference in Glyc a

  Baseline and 8 weeks

• Difference in C-Reactive Protein (CRP)

  Baseline and 8 weeks

• Difference in Interleukin-10 (L-10)

  Baseline and 8 weeks

• Difference in Tumor Necrosis Factor-alpha (TNF-alpha)

  Baseline and 8 weeks

• Difference in Cytokines and Inflammatory Proteins

  Baseline and 8 weeks

Study Arms (2)

Whole Food Plant-Based Diet

EXPERIMENTAL

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

Behavioral: Whole Foods Plant-Based Diet

Usual Firehouse Diet

ACTIVE COMPARATOR

Participants will be asked to consume their usual firehouse meals.

Behavioral: Usual Firehouse Diet

Interventions

Usual Firehouse Diet BEHAVIORAL

Usual firehouse meals.

Usual Firehouse Diet

Whole Foods Plant-Based Diet BEHAVIORAL

Whole foods, predominantly plant-based diet, with the addition of fish, eggs, and fermented dairy.

Whole Food Plant-Based Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Active SF firefighter
• Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes, etc.)
• Willing to complete 4 clinic visits

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Links

• Study description and sign up

MeSH Terms

Conditions

Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher D Gardner, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: January 9, 2025
• Primary Completion: March 11, 2026
• Study Completion: March 11, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)