IGNITE Firefighters' Health
NCT Number: NCT06567561
Acronym: IGNITE FH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cancer|Inflammation|Microbiome|Immune Function
Interventions: BEHAVIORAL: Whole Foods Plant-Based Diet|BEHAVIORAL: Usual Firehouse Diet
Sponsor: Stanford University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-09
Completion Date: 2025-09-09

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.

Primary Outcome Measures: 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 Outcome Measures: Difference in Glyc a, Difference in the 8-week change from baseline in Glyc a between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in C-Reactive Protein (CRP), Difference in the 8-week change from baseline in C-Reactive Protein (CRP) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Interleukin-10 (L-10), Difference in the 8-week change from baseline in Interleukin-10 (IL-10) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Tumor Necrosis Factor-alpha (TNF-alpha), Difference in the 8-week change from baseline in Tumor Necrosis Factor-alpha (TNF-alpha) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Cytokines and Inflammatory Proteins, Difference in the 8-week change from baseline in a panel of cytokines and inflammatory proteins using the NUcleic acid Linked Immuno-Sandwich Assay (NULISA™) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Calprotectin, Difference in the 8-week change from baseline in Calprotectin between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in 8-hydroxy-2'-deoxyguanosine (8-OH-dG), Difference in the 8-week change from baseline in 8-hydroxy-2'-deoxyguanosine (8-OH-dG) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in General DNA Damage, Difference in the 8-week change from baseline in general DNA damage between the whole-food plant-based vs. usual diet groups, using the Comet Assay., Baseline and 8 weeks|Difference in Superoxide dismutase (SOD), Difference in the 8-week change from baseline in Superoxide dismutase (SOD) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Catalase, Difference in the 8-week change from baseline in Catalase between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Glutathione peroxidase (GPx), Difference in the 8-week change from baseline in Glutathione peroxidase (GPx) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Total Glutathione [Glutathione (GSH) + Glutathione disulfide (GSSG)], Difference in the 8-week change from baseline in Total Glutathione \[Glutathione (GSH) + Glutathione disulfide (GSSG)\] between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Lipid Peroxidation, Difference in the 8-week change from baseline in Lipid Peroxidation between the whole-food plant-based vs. usual diet groups, using the Thiobarbituric acid-reactive substance (TBARS) assay., Baseline and 8 weeks|Difference in F2-isoprostanes, Difference in the 8-week change from baseline in F2-isoprostanes between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Protein Carbonyl (protein oxidation), Difference in the 8-week change from baseline in Protein Carbonyl (a measure of protein oxidation) between the whole-food plant-based vs. usual diet groups, using the enzyme-linked immunosorbent assay (ELISA)., Baseline and 8 weeks|Difference in Total Antioxidant Capacity (TAC), Difference in the 8-week change from baseline in Total Antioxidant Capacity (TAC) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Fasting Glucose, Difference in the 8-week change from baseline in Fasting Glucose between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Fasting Insulin, Difference in the 8-week change from baseline in Fasting Insulin between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Low-Density-Lipoprotein Cholesterol (LDL), Difference in the 8-week change from baseline in Low-Density-Lipoprotein Cholesterol (LDL) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in High-Density-Lipoprotein Cholesterol (HDL), Difference in the 8-week change from baseline in High-Density-Lipoprotein Cholesterol (HDL) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Triglycerides (TRGs), Difference in the 8-week change from baseline in Triglycerides (TRGs) between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Telomeres, Difference in the 8-week change from baseline in Telomeres between the whole-food plant-based vs. usual diet groups., Baseline and 8 weeks|Difference in Epigenetic Age, Difference in the 8-week change from baseline in Epigenetic Age between the whole-food plant-based vs. usual diet groups, assessed by Epigenetic Clocks., Baseline and 8 weeks|Difference in Gut Microbiome Composition, Difference in the 8-week change from baseline in Gut Microbiome Composition between the whole-food plant-based vs. usual diet groups, assessed by Metagenomic Sequencing., Baseline and 8 weeks|Difference in Metabolomic Profiles, Difference in the 8-week change from baseline in Gut Microbiome Composition between the whole-food plant-based vs. usual diet groups, assessed by assessed by Targeted and Untargeted Metabolomics, Baseline and 8 weeks