CancerNCT06567561
Implementing Good Nutrition to Improve, Transform, and Enhance (IGNITE) Firefighters' Health
A study testing Whole Foods Plant-Based Diet and Usual Firehouse Diet in people with Cancer and Inflammation, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Inflammation, Microbiome
- What is being tested?
- Whole Foods Plant-Based Diet and Usual Firehouse Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+
- Active SF firefighter
- Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes, etc.)
- Willing to complete 4 clinic visits
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Investigators hope to learn about potential dietary intervention strategies (specifically a whole-food, plant-based diet) that may help lower cancer markers in firefighters.
Read the 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.
- Conditions
- Cancer, Inflammation, Microbiome, Immune Function
- Being tested
- Whole Foods Plant-Based Diet, Usual Firehouse Diet
- Keywords
- Cancer, Inflammation, Microbiome, Immune function
- Medical subject headings
- Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Foods Plant-Based DietBehavioural
Whole foods, predominantly plant-based diet, with the addition of fish, eggs, and fermented dairy.
Usual Firehouse DietBehavioural
Usual firehouse meals.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Whole Foods Plant-Based Diet |
| Usual Firehouse Diet | Active comparator | Participants will be asked to consume their usual firehouse meals. Receives: Behavioral: Usual Firehouse Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start9 Jan 2025
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Gardner, Stanford University
- Investigators
- Christopher D Gardner, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567561
- Sponsor's protocol ID
- IRB-75777
- Other IDs
- NCI-2025-01830
- Status last verified
- Apr 2026
- First submitted
- 20 Aug 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Good Nutrition to Improve, Transform, and Enhance (IGNITE) Firefighters' Health
- ClinicalTrials.gov ID
- NCT06567561
- Acronym / sponsor ID
- IRB-75777
- Conditions
- Cancer, Inflammation, Microbiome, Immune Function
- Keywords
- Cancer, Inflammation, Microbiome, Immune function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Food Plant-Based Diet | Experimental | Behavioral: Whole Foods Plant-Based DietParticipants will be asked to consume and predominantly vegan, whole-foods diet, with the addition of fish, eggs, and fermented dairy. |
| Usual Firehouse Diet | Active comparator | Behavioral: Usual Firehouse DietParticipants will be asked to consume their usual firehouse meals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18+
- Active SF firefighter
- Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes, etc.)
- Willing to complete 4 clinic visits
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Foods Plant-Based DietWhole foods, predominantly plant-based diet, with the addition of fish, eggs, and fermented dairy. | Behavioural | Whole Food Plant-Based Diet |
| Usual Firehouse DietUsual firehouse meals. | Behavioural | Usual Firehouse Diet |
Primary outcome
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.
23 secondary outcomes
Difference in Glyc a
Time frame: Baseline and 8 weeks
Difference in C-Reactive Protein (CRP)
Time frame: Baseline and 8 weeks
Difference in Interleukin-10 (L-10)
Time frame: Baseline and 8 weeks
Difference in Tumor Necrosis Factor-alpha (TNF-alpha)
Time frame: Baseline and 8 weeks
Difference in Cytokines and Inflammatory Proteins
Time frame: Baseline and 8 weeks
Difference in Calprotectin
Time frame: Baseline and 8 weeks
Difference in 8-hydroxy-2'-deoxyguanosine (8-OH-dG)
Time frame: Baseline and 8 weeks
Difference in Lipid Peroxidation
Time frame: Baseline and 8 weeks
Difference in Protein Carbonyl (protein oxidation)
Time frame: Baseline and 8 weeks
Difference in Fasting Glucose
Time frame: Baseline and 8 weeks
Difference in Fasting Insulin
Time frame: Baseline and 8 weeks
Difference in Low-Density-Lipoprotein Cholesterol (LDL)
Time frame: Baseline and 8 weeks
Difference in High-Density-Lipoprotein Cholesterol (HDL)
Time frame: Baseline and 8 weeks
Difference in Triglycerides (TRGs)
Time frame: Baseline and 8 weeks
Difference in Telomeres
Time frame: Baseline and 8 weeks
Difference in Epigenetic Age
Time frame: Baseline and 8 weeks
Difference in Gut Microbiome Composition
Time frame: Baseline and 8 weeks
Difference in Metabolomic Profiles
Time frame: Baseline and 8 weeks
Difference in 4-hydroxynonenal (HNE)
Time frame: Baseline and 8 weeks
Difference in body composition
Time frame: Baseline and 8 weeks
Difference in weight
Time frame: Baseline and 8 weeks
Difference in systolic blood pressure
Time frame: Baseline and 8 weeks
Difference in diastolic blood pressure
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Study description and sign upLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Gardner, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Foods Plant-Based Diet and Usual Firehouse Diet in people with Cancer and Inflammation, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in IL-6 (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.