Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT06567561
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06567561
Study Brief:
Protocol Section:
NCT06567561