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Clinical Trials/NCT06567561
NCT06567561
Active, Not Recruiting
N/A

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

Stanford University1 site in 1 country120 target enrollmentJanuary 9, 2025

Overview

Phase
N/A
Intervention
Whole Foods Plant-Based Diet
Conditions
Cancer
Sponsor
Stanford University
Enrollment
120
Locations
1
Primary Endpoint
Difference in IL-6
Status
Active, Not Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 9, 2025
End Date
March 30, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Arms & Interventions

Whole Food Plant-Based Diet

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

Intervention: Whole Foods Plant-Based Diet

Usual Firehouse Diet

Participants will be asked to consume their usual firehouse meals.

Intervention: Usual Firehouse Diet

Outcomes

Primary Outcomes

Difference in IL-6

Time Frame: Baseline and 8 weeks

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

Secondary Outcomes

  • Difference in Protein Carbonyl (protein oxidation)(Baseline and 8 weeks)
  • 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)
  • Difference in Calprotectin(Baseline and 8 weeks)
  • Difference in 8-hydroxy-2'-deoxyguanosine (8-OH-dG)(Baseline and 8 weeks)
  • Difference in Lipid Peroxidation(Baseline and 8 weeks)
  • Difference in Fasting Glucose(Baseline and 8 weeks)
  • Difference in Fasting Insulin(Baseline and 8 weeks)
  • Difference in Low-Density-Lipoprotein Cholesterol (LDL)(Baseline and 8 weeks)
  • Difference in High-Density-Lipoprotein Cholesterol (HDL)(Baseline and 8 weeks)
  • Difference in Triglycerides (TRGs)(Baseline and 8 weeks)
  • Difference in Telomeres(Baseline and 8 weeks)
  • Difference in Epigenetic Age(Baseline and 8 weeks)
  • Difference in Gut Microbiome Composition(Baseline and 8 weeks)
  • Difference in Metabolomic Profiles(Baseline and 8 weeks)
  • Difference in 4-hydroxynonenal (HNE)(Baseline and 8 weeks)
  • Difference in body composition(Baseline and 8 weeks)
  • Difference in weight(Baseline and 8 weeks)
  • Difference in systolic blood pressure(Baseline and 8 weeks)
  • Difference in diastolic blood pressure(Baseline and 8 weeks)

Study Sites (1)

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