Savannah Environmental Nutrition Study (SENS) Food as Prevention: A Community-Based Nutrition Intervention to Reduce Air Pollution-Related Inflammation and Oxidative Stress in Residents Near the Port of Savannah
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Participant Retention Rate
研究概览
简要总结
This pilot clinical trial will evaluate the feasibility and potential health effects of a nutrition-based intervention among adults living in communities affected by air pollution near the Port of Savannah, Georgia. Participants will be assigned to either a nutrition intervention group or a control group. The intervention group will receive biweekly grocery deliveries emphasizing foods naturally rich in antioxidants and anti-inflammatory nutrients, including vitamins C and E, omega-3 fatty acids, and polyphenols. The control group will continue their usual dietary practices during the study period.
The study will evaluate whether the nutritional intervention is associated with changes in selected respiratory, oxidative stress, and cardiometabolic health indicators. Assessments will include fractional exhaled nitric oxide (FeNO) as a marker of airway inflammation, hydrogen peroxide (H₂O₂) in exhaled breath condensate as a marker of oxidative stress, systolic and diastolic blood pressure, resting heart rate, and glycated hemoglobin (HbA1c). Indoor concentrations of particulate matter (PM), nitrogen dioxide (NO₂), and ozone (O₃) will also be monitored to characterize participants' household air-pollution exposures. Measurements will be collected at baseline and at subsequent study assessments, as specified for each outcome. Findings from this pilot study will be used to evaluate feasibility, estimate changes in health outcomes, and inform the design of a larger clinical trial investigating nutritional approaches to potentially reduce health effects associated with air-pollution exposure.
详细描述
Exposure to air pollution is associated with oxidative stress and inflammatory responses that may contribute to adverse respiratory and cardiovascular health effects. Nutritional factors may influence antioxidant defenses and inflammatory pathways; however, relatively little intervention research has examined whether improving dietary intake can modify biological responses among individuals experiencing ongoing environmental air-pollution exposures. This pilot clinical trial will investigate the feasibility and potential effects of a food-based nutritional intervention among adults residing in communities affected by air pollution near the Port of Savannah, Georgia.
The study will include 20 participants, who will be assigned to a nutrition intervention group or a control group according to the study's approved allocation procedure. Participants in the intervention group will receive biweekly grocery deliveries emphasizing foods naturally rich in antioxidant and anti-inflammatory dietary components, including vitamins C and E, omega-3 fatty acids, and polyphenols. Participants assigned to the control group will maintain their usual dietary practices during the active study period. Intervention feasibility and adherence will also be evaluated to inform the design and implementation of a future larger-scale trial.
Respiratory and oxidative-stress assessments will include fractional exhaled nitric oxide (FeNO), measured using a NIOX Mini device, and hydrogen peroxide (H₂O₂) measured in exhaled breath condensate collected using an RTube® collection system. Cardiometabolic assessments will include systolic and diastolic blood pressure and resting heart rate measured using a validated automatic upper-arm blood pressure monitor. HbA1c will be assessed at baseline and the final assessment as an exploratory measure of longer-term glycemic status. Indoor particulate matter (PM), nitrogen dioxide (NO₂), and ozone (O₃) will also be monitored to characterize household air-pollution exposures.
Study assessments will be performed at baseline and at subsequent study time points according to the protocol. Changes in respiratory, oxidative-stress, and cardiometabolic measures will be compared over time and between study groups. Because this is a pilot study, the findings will primarily be used to evaluate study feasibility, intervention adherence, outcome variability, and preliminary effect estimates rather than to establish definitive clinical efficacy. The results will provide information needed to refine the intervention, outcome-selection strategy, and study procedures and to estimate parameters needed for the design of a larger clinical trial.
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
- •Residing in Port Wentworth or the Savannah main Channel at a 3-mile radius for the prior 12 months and not planning to move during the study.
- •Non-smoking status (or specified ANY smoking history)
- •Absence of pre-existing chronic respiratory conditions (Asthma, Chronic Obstructive Pulmonary Disease, Seasonal respiratory allergies that require the use of antihistamines or immunosuppressants more than once a month, Chronic Bronchitis, and Heart Failure or any condition that would put participants at a greater risk than other participants for a pre-existing condition.
- •Willingness and ability to participate in home monitoring protocols
- •Willingness to receive and use grocery delivery for the nutrition intervention
- •Willingness and ability to follow the study procedures
- •Own a refrigerator
- •Allow investigators to do 1.5 hour home visits, and several calls and texts
- •Having a kitchen and the ability to prepare, cook meals, and eat them at home
- •Living in a household with 4 or fewer people
排除标准
- •Individuals unable to follow study procedures
- •Antihistamines or any immunosuppressors, ongoing cancer treatment or within the past 5 years
- •Individuals unable to read, speak, and/or understand English or Spanish
- •Any food allergy
- •Strong dislike to most vegetables or fruits
- •Having ever been diagnosed with an eating disorder or autoimmune disorder
- •Being currently treated for any type of cancer
- •Households with 5 or more people living in the same space
研究组 & 干预措施
Nutrition Intervention
Participants assigned to the nutrition intervention group will receive biweekly grocery deliveries emphasizing foods naturally rich in antioxidant and anti-inflammatory dietary components, including vitamins C and E, omega-3 fatty acids, and polyphenols. Participants will receive guidance on incorporating the provided foods into their usual diet throughout the intervention period. Respiratory, oxidative-stress, cardiometabolic, and environmental exposure measures will be assessed according to the study protocol.
干预措施: Antioxidant- and Nutrient-Rich Food-Based Nutrition Intervention (Other)
Control Group
Participants assigned to the control group will continue their usual dietary practices during the active study period and will not receive the study grocery intervention during this period. The same study assessments will be conducted according to the study protocol to allow comparison of changes in health outcomes between the intervention and control groups.
结局指标
主要结局
Participant Retention Rate
时间窗: Baseline through Week 12.
Through the Final Assessment Participant retention will be assessed as the proportion of enrolled participants who complete the study through the final Week 12 assessment. Retention rate will be calculated as the number of enrolled participants who complete the final assessment, divided by the total number of participants enrolled at baseline, multiplied by 100. A retention rate of ≥80% will be considered evidence of acceptable feasibility for a future larger-scale trial.
次要结局
- Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)(Baseline, approximately Week 6, and Week 12)
- Change From Baseline in Hydrogen Peroxide (H₂O₂) Concentration in Exhaled Breath Condensate(Baseline, approximately Week 6, and Week 12)
- Change From Baseline in Systolic Blood Pressure(Baseline, approximately Week 6, and Week 12)
- Change From Baseline in Diastolic Blood Pressure(Baseline, approximately Week 6, and Week 12)
- Change From Baseline in Resting Heart Rate(Baseline, approximately Week 6, and Week 12)
- Change From Baseline in Glycated Hemoglobin (HbA1c)(Baseline and Week 12)
- Recruitment/Accrual Rate(From initiation of recruitment through completion of study enrollment, approximately 6 months.)
- Adherence to the Food-Based Nutrition Intervention(Throughout the 12-week intervention.)
研究者
Atin Adhikari
Professor of Environmental Health Sciences
Georgia Southern University