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

NCT07797413 | Not Yet Recruiting

• 1 other identifier: H26382
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Air Pollution Exposure; Oxidative Stress; Airway Inflammation

Keywords

Air pollution; Nutrition intervention; Oxidative stress; Exhaled nitric oxide; FeNO; Exhaled breath condensate; Hydrogen peroxide; Particulate matter; Nitrogen dioxide; Ozone; Cardiometabolic health

Outcome Measures

Primary Outcomes (1)

• Participant Retention Rate

  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.

  Baseline through Week 12.

Secondary Outcomes (8)

• 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

Study Arms (2)

Nutrition Intervention

EXPERIMENTAL

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.

Other: Antioxidant- and Nutrient-Rich Food-Based Nutrition Intervention

Control Group

NO INTERVENTION

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.

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.

Nutrition Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia Southern University: lead

Study Sites (1)

Georgia Southern University and GROW Initiative GA

Savannah, Georgia, 31419, United States

Location

MeSH Terms

Interventions

Antioxidants

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Central Study Contacts

Atin Adhikari, PhD

CONTACT

912-478-2289; aadhikari@georgiasouthern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Environmental Health Sciences

Model Details: Participants will be randomly assigned to one of two parallel study groups: a nutrition intervention group or a control group. 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 in the control group will maintain their usual dietary practices during the active study period. Respiratory, oxidative-stress, cardiometabolic, and environmental exposure measures will be assessed according to the study protocol and compared between groups and over time.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)