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

Part of paid clinical trials in Savannah, Georgia.

Sponsor
Georgia Southern University
Study ID
NCT07797413
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Air Pollution Exposure
  • Airway Inflammation
  • Oxidative Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Antioxidant- and Nutrient-Rich Food-Based Nutrition Intervention — OTHER
    Participants assigned to the intervention will receive biweekly grocery deliveries containing selected 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 dietary patterns. The intervention is designed to increase consumption of nutrient-rich foods and to evaluate the feasibility and potential effects of this dietary approach on respiratory inflammation, oxidative stress, and cardiometabolic outcomes among adults living in a community affected by air pollution.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • No Intervention: 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.

Primary Outcome Measure

Participant Retention Rate [ Time Frame: Baseline through Week 12. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Georgia Southern University and GROW Initiative GASavannahGeorgia31419
Atin Adhikari, PhD
[email protected]
(912) 4782289

Find similar trials in Savannah, GA

By research site
Georgia Southern University and GROW Initiative GA· Savannah, GA

Related Studies