Clinical trial NCT06567561: IGNITE Firefighters' Health
Official title: Implementing Good Nutrition to Improve, Transform, and Enhance Firefighters' Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Inflammation
Microbiome
Immune Function
Keywords: Cancer
Inflammation
Microbiome
Immune function
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Difference in IL-6
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Difference in Glyc a
timeFrame: Baseline and 8 weeks
measure: Difference in C-Reactive Protein (CRP)
timeFrame: Baseline and 8 weeks
measure: Difference in Interleukin-10 (L-10)
timeFrame: Baseline and 8 weeks
measure: Difference in Tumor Necrosis Factor-alpha (TNF-alpha)
timeFrame: Baseline and 8 weeks
measure: Difference in Cytokines and Inflammatory Proteins
timeFrame: Baseline and 8 weeks
measure: Difference in Calprotectin
timeFrame: Baseline and 8 weeks
measure: Difference in 8-hydroxy-2'-deoxyguanosine (8-OH-dG)
timeFrame: Baseline and 8 weeks
measure: Difference in Lipid Peroxidation
timeFrame: Baseline and 8 weeks
measure: Difference in Protein Carbonyl (protein oxidation)
timeFrame: Baseline and 8 weeks
measure: Difference in Fasting Glucose
timeFrame: Baseline and 8 weeks
measure: Difference in Fasting Insulin
timeFrame: Baseline and 8 weeks
measure: Difference in Low-Density-Lipoprotein Cholesterol (LDL)
timeFrame: Baseline and 8 weeks
measure: Difference in High-Density-Lipoprotein Cholesterol (HDL)
timeFrame: Baseline and 8 weeks
measure: Difference in Triglycerides (TRGs)
timeFrame: Baseline and 8 weeks
measure: Difference in Telomeres
timeFrame: Baseline and 8 weeks
measure: Difference in Epigenetic Age
timeFrame: Baseline and 8 weeks
measure: Difference in Gut Microbiome Composition
timeFrame: Baseline and 8 weeks
measure: Difference in Metabolomic Profiles
timeFrame: Baseline and 8 weeks
measure: Difference in 4-hydroxynonenal (HNE)
timeFrame: Baseline and 8 weeks
measure: Difference in body composition
timeFrame: Baseline and 8 weeks
measure: Difference in weight
timeFrame: Baseline and 8 weeks
measure: Difference in systolic blood pressure
timeFrame: Baseline and 8 weeks
measure: Difference in diastolic blood pressure
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Christopher D Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
References: