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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-01830 | Registry Identifier | National Cancer Institute Clinical Trials Reporting Program |
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Investigators hope to learn about potential dietary intervention strategies (specifically a whole-food, plant-based diet) that may help lower cancer markers in firefighters.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual Firehouse Diet | Active Comparator | Participants will be asked to consume their usual firehouse meals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Foods Plant-Based Diet | Behavioral | Whole foods, predominantly plant-based diet, with the addition of fish, eggs, and fermented dairy. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Gardner, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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| Label | URL |
|---|---|
| Study description and sign up | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Usual Firehouse Diet | Behavioral | Usual firehouse meals. |
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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 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 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 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 |
| Difference in 4-hydroxynonenal (HNE) | Difference in the 8-week change from baseline in 4-hydroxynonenal (HNE) between the whole-food plant-based vs. usual diet groups. | Baseline and 8 weeks |
| Difference in body composition | Difference in the 8-week change from baseline in body composition between the whole-food plant-based vs. usual diet groups, as assessed by dual energy x-ray absorptiometry scan (DEXA) scans. | Baseline and 8 weeks |
| Difference in weight | Difference in the 8-week change from baseline in weight between the whole-food plant-based vs. usual diet groups. | Baseline and 8 weeks |
| Difference in systolic blood pressure | Difference in the 8-week change from baseline in systolic blood pressure between the whole-food plant-based vs. usual diet groups. | Baseline and 8 weeks |
| Difference in diastolic blood pressure | Difference in the 8-week change from baseline in diastolic blood pressure between the whole-food plant-based vs. usual diet groups. | Baseline and 8 weeks |