NCT06567561进行中（未招募）不适用
Implementing Good Nutrition to Improve, Transform, and Enhance Firefighters' Health
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Difference in IL-6
研究概览
简要总结
Investigators hope to learn about potential dietary intervention strategies (specifically a whole-food, plant-based diet) that may help lower cancer markers in firefighters.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active SF firefighter
- •Willing to consume a plant-based diet (vegetables, fruit, whole grains, legumes, etc.)
- •Willing to complete 4 clinic visits
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Whole Foods Plant-Based Diet (Behavioral)
Usual Firehouse Diet
Active Comparator
Participants will be asked to consume their usual firehouse meals.
干预措施: Usual Firehouse Diet (Behavioral)
结局指标
主要结局
Difference in IL-6
时间窗: 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.
次要结局
- Difference in Protein Carbonyl (protein oxidation)(Baseline and 8 weeks)
- Difference in Glyc a(Baseline and 8 weeks)
- Difference in C-Reactive Protein (CRP)(Baseline and 8 weeks)
- Difference in Interleukin-10 (L-10)(Baseline and 8 weeks)
- Difference in Tumor Necrosis Factor-alpha (TNF-alpha)(Baseline and 8 weeks)
- Difference in Cytokines and Inflammatory Proteins(Baseline and 8 weeks)
- Difference in Calprotectin(Baseline and 8 weeks)
- Difference in 8-hydroxy-2'-deoxyguanosine (8-OH-dG)(Baseline and 8 weeks)
- Difference in Lipid Peroxidation(Baseline and 8 weeks)
- Difference in Fasting Glucose(Baseline and 8 weeks)
- Difference in Fasting Insulin(Baseline and 8 weeks)
- Difference in Low-Density-Lipoprotein Cholesterol (LDL)(Baseline and 8 weeks)
- Difference in High-Density-Lipoprotein Cholesterol (HDL)(Baseline and 8 weeks)
- Difference in Triglycerides (TRGs)(Baseline and 8 weeks)
- Difference in Telomeres(Baseline and 8 weeks)
- Difference in Epigenetic Age(Baseline and 8 weeks)
- Difference in Gut Microbiome Composition(Baseline and 8 weeks)
- Difference in Metabolomic Profiles(Baseline and 8 weeks)
- Difference in 4-hydroxynonenal (HNE)(Baseline and 8 weeks)
- Difference in body composition(Baseline and 8 weeks)
- Difference in weight(Baseline and 8 weeks)
- Difference in systolic blood pressure(Baseline and 8 weeks)
- Difference in diastolic blood pressure(Baseline and 8 weeks)
研究者
研究点 (1)
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