Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT06567561
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IGNITE Firefighters' Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in IL-6', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in IL-6 between the whole-food plant-based vs. usual diet groups.'}], 'secondaryOutcomes': [{'measure': 'Difference in Glyc a', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in Glyc a between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in C-Reactive Protein (CRP)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in C-Reactive Protein (CRP) between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in Interleukin-10 (L-10)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in Interleukin-10 (IL-10) between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in Tumor Necrosis Factor-alpha (TNF-alpha)', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Difference in Cytokines and Inflammatory Proteins', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Difference in Calprotectin', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in Calprotectin between the whole-food plant-based vs. usual diet groups.'}, {'measure': "Difference in 8-hydroxy-2'-deoxyguanosine (8-OH-dG)", 'timeFrame': 'Baseline and 8 weeks', 'description': "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."}, {'measure': 'Difference in Lipid Peroxidation', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Difference in Protein Carbonyl (protein oxidation)', 'timeFrame': 'Baseline and 8 weeks', 'description': '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).'}, {'measure': 'Difference in Fasting Glucose', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in Fasting Glucose between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in Fasting Insulin', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in Fasting Insulin between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in Low-Density-Lipoprotein Cholesterol (LDL)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in Low-Density-Lipoprotein Cholesterol (LDL) between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in High-Density-Lipoprotein Cholesterol (HDL)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in High-Density-Lipoprotein Cholesterol (HDL) between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in Triglycerides (TRGs)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in Triglycerides (TRGs) between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in Telomeres', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in Telomeres between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in Epigenetic Age', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Difference in Gut Microbiome Composition', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Difference in Metabolomic Profiles', 'timeFrame': 'Baseline and 8 weeks', 'description': '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'}, {'measure': 'Difference in 4-hydroxynonenal (HNE)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in 4-hydroxynonenal (HNE) between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in body composition', 'timeFrame': 'Baseline and 8 weeks', 'description': '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.'}, {'measure': 'Difference in weight', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in weight between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in systolic blood pressure', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in systolic blood pressure between the whole-food plant-based vs. usual diet groups.'}, {'measure': 'Difference in diastolic blood pressure', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Difference in the 8-week change from baseline in diastolic blood pressure between the whole-food plant-based vs. usual diet groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Inflammation', 'Microbiome', 'Immune function'], 'conditions': ['Cancer', 'Inflammation', 'Microbiome', 'Immune Function']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://med.stanford.edu/nutrition/research/current-studies/ignite-firefighters--health.html', 'label': 'Study description and sign up'}]}, 'descriptionModule': {'briefSummary': 'Investigators hope to learn about potential dietary intervention strategies (specifically a whole-food, plant-based diet) that may help lower cancer markers in firefighters.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18+\n* Active SF firefighter\n* Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes, etc.)\n* Willing to complete 4 clinic visits\n\nExclusion Criteria:\n\n* Weight \\< 110 lb\n* BMI \\>= 40\n* Self-reported uncontrolled hypercholesterolemia, hypertension or diabetes\n* Pregnant, lactating, or planning to become pregnant during the course of the study.\n* Use of any of the following drugs/supplements within the last 2 months:\n\n * systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral);\n * corticosteroids (intravenous, intramuscular, oral, nasal or inhaled);\n * cytokines;\n * methotrexate or immunosuppressive cytotoxic agents.\n* 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\n* 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\n* 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.\n* 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.\n* Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection, multiple sclerosis, and Graves' disease.\n* Surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.\n* Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other nicotine-containing products\n* Regular use of prescription opiate pain medication"}, 'identificationModule': {'nctId': 'NCT06567561', 'acronym': 'IGNITE FH', 'briefTitle': "IGNITE Firefighters' Health", 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': "Implementing Good Nutrition to Improve, Transform, and Enhance Firefighters' Health", 'orgStudyIdInfo': {'id': '75777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole Food Plant-Based Diet', 'description': 'Participants will be asked to consume and predominantly vegan, whole-foods diet, with the addition of fish, eggs, and fermented dairy.', 'interventionNames': ['Behavioral: Whole Foods Plant-Based Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Firehouse Diet', 'description': 'Participants will be asked to consume their usual firehouse meals.', 'interventionNames': ['Behavioral: Usual Firehouse Diet']}], 'interventions': [{'name': 'Whole Foods Plant-Based Diet', 'type': 'BEHAVIORAL', 'description': 'Whole foods, predominantly plant-based diet, with the addition of fish, eggs, and fermented dairy.', 'armGroupLabels': ['Whole Food Plant-Based Diet']}, {'name': 'Usual Firehouse Diet', 'type': 'BEHAVIORAL', 'description': 'Usual firehouse meals.', 'armGroupLabels': ['Usual Firehouse Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roujheen Sabetan, MPH', 'role': 'CONTACT', 'email': 'rsabetan@stanford.edu', 'phone': '650-736-8577'}, {'name': 'Christopher Gardner, PhD', 'role': 'CONTACT'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Roujheen Sabetan, MPH', 'role': 'CONTACT', 'email': 'rsabetan@stanford.edu', 'phone': '650-736-8577'}, {'name': 'Jennifer Robinson, PhD', 'role': 'CONTACT', 'email': 'jlmorris@stanford.edu', 'phone': '650-736-8577'}], 'overallOfficials': [{'name': 'Christopher D Gardner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher Gardner', 'investigatorAffiliation': 'Stanford University'}}}}