Cancer, Immune Function, Inflammation, Microbiome
Conditions
Keywords
Cancer, Inflammation, Microbiome, Immune function
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.
Interventions
BEHAVIORALWhole Foods Plant-Based Diet
Whole foods, predominantly plant-based diet, with the addition of fish, eggs, and fermented dairy.
BEHAVIORALUsual Firehouse Diet
Usual firehouse meals.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in IL-6 | 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
| Measure | Time frame | Description |
|---|---|---|
| Difference in Glyc a | Baseline and 8 weeks | Difference in the 8-week change from baseline in Glyc a between the whole-food plant-based vs. usual diet groups. |
| Difference in C-Reactive Protein (CRP) | Baseline and 8 weeks | Difference in the 8-week change from baseline in C-Reactive Protein (CRP) between the whole-food plant-based vs. usual diet groups. |
| Difference in Interleukin-10 (L-10) | Baseline and 8 weeks | Difference in the 8-week change from baseline in Interleukin-10 (IL-10) between the whole-food plant-based vs. usual diet groups. |
| Difference in Tumor Necrosis Factor-alpha (TNF-alpha) | Baseline and 8 weeks | 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. |
| Difference in Cytokines and Inflammatory Proteins | Baseline and 8 weeks | 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. |
| Difference in Calprotectin | Baseline and 8 weeks | Difference in the 8-week change from baseline in Calprotectin between the whole-food plant-based vs. usual diet groups. |
| Difference in 8-hydroxy-2'-deoxyguanosine (8-OH-dG) | Baseline and 8 weeks | 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. |
| Difference in Lipid Peroxidation | Baseline and 8 weeks | 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. |
| Difference in Protein Carbonyl (protein oxidation) | Baseline and 8 weeks | 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). |
| Difference in Fasting Glucose | Baseline and 8 weeks | Difference in the 8-week change from baseline in Fasting Glucose between the whole-food plant-based vs. usual diet groups. |
| Difference in Fasting Insulin | Baseline and 8 weeks | Difference in the 8-week change from baseline in Fasting Insulin between the whole-food plant-based vs. usual diet groups. |
| Difference in Low-Density-Lipoprotein Cholesterol (LDL) | Baseline and 8 weeks | Difference in the 8-week change from baseline in Low-Density-Lipoprotein Cholesterol (LDL) between the whole-food plant-based vs. usual diet groups. |
| Difference in High-Density-Lipoprotein Cholesterol (HDL) | Baseline and 8 weeks | Difference in the 8-week change from baseline in High-Density-Lipoprotein Cholesterol (HDL) between the whole-food plant-based vs. usual diet groups. |
| Difference in Triglycerides (TRGs) | Baseline and 8 weeks | Difference in the 8-week change from baseline in Triglycerides (TRGs) between the whole-food plant-based vs. usual diet groups. |
| Difference in Telomeres | Baseline and 8 weeks | Difference in the 8-week change from baseline in Telomeres between the whole-food plant-based vs. usual diet groups. |
| Difference in Epigenetic Age | Baseline and 8 weeks | 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. |
| Difference in Gut Microbiome Composition | Baseline and 8 weeks | 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. |
| Difference in Metabolomic Profiles | Baseline and 8 weeks | 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 |
| Difference in 4-hydroxynonenal (HNE) | Baseline and 8 weeks | Difference in the 8-week change from baseline in 4-hydroxynonenal (HNE) between the whole-food plant-based vs. usual diet groups. |
| Difference in body composition | Baseline and 8 weeks | 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. |
| Difference in weight | Baseline and 8 weeks | Difference in the 8-week change from baseline in weight between the whole-food plant-based vs. usual diet groups. |
| Difference in systolic blood pressure | Baseline and 8 weeks | Difference in the 8-week change from baseline in systolic blood pressure between the whole-food plant-based vs. usual diet groups. |
| Difference in diastolic blood pressure | Baseline and 8 weeks | Difference in the 8-week change from baseline in diastolic blood pressure between the whole-food plant-based vs. usual diet groups. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristopher D Gardner, PhD
Stanford University
Outcome results
None listed