Savannah Environmental Nutrition Study (SENS): nutrition Intervention to Reduce Air Pollution-Related Airway Inflammation and Oxidative Stress

Exposure to air pollution is associated with oxidative stress and inflammatory responsesthat may contribute to adverse respiratory and cardiovascular health effects. Nutritionalfactors may influence antioxidant defenses and inflammatory pathways; however, relativelylittle intervention research has examined whether improving dietary intake can modifybiological responses among individuals experiencing ongoing environmental air‐pollutionexposures. This pilot clinical trial will investigate the feasibility and potentialeffects of a food‐based nutritional intervention among adults residing in communitiesaffected by air pollution near the Port of Savannah, Georgia.The study will include 20 participants, who will be assigned to a nutrition interventiongroup or a control group according to the study's approved allocation procedure.Participants in the intervention group will receive biweekly grocery deliveriesemphasizing foods naturally rich in antioxidant and anti‐inflammatory dietary components,including vitamins C and E, omega‐3 fatty acids, and polyphenols. Participants assignedto the control group will maintain their usual dietary practices during the active studyperiod. Intervention feasibility and adherence will also be evaluated to inform thedesign 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 inexhaled breath condensate collected using an RTube® collection system. Cardiometabolicassessments will include systolic and diastolic blood pressure and resting heart ratemeasured using a validated automatic upper‐arm blood pressure monitor. HbA1c will beassessed at baseline and the final assessment as an exploratory measure of longer‐termglycemic 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 pointsaccording to the protocol. Changes in respiratory, oxidative‐stress, and cardiometabolicmeasures will be compared over time and between study groups. Because this is a pilotstudy, the findings will primarily be used to evaluate study feasibility, interventionadherence, outcome variability, and preliminary effect estimates rather than to establishdefinitive clinical efficacy. The results will provide information needed to refine theintervention, outcome‐selection strategy, and study procedures and to estimate parametersneeded for the design of a larger clinical trial.