Savannah Environmental Nutrition Study (SENS): Nutrition Intervention to Reduce Air Pollution-Related Airway Inflammation and Oxidative Stress
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
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Atin Adhikari, PhD
- 電話番号：912-478-2289
- メール：aadhikari@georgiasouthern.edu
研究場所
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Georgia
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Savannah、Georgia、アメリカ、31419
- Georgia Southern University and GROW Initiative GA
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コンタクト：
- Atin Adhikari, PhD
- 電話番号：(912) 4782289
- メール：aadhikari@georgiasouthern.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participant Retention Rate
時間枠：Baseline through Week 12.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
時間枠：Baseline, approximately Week 6, and Week 12
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Fractional exhaled nitric oxide (FeNO) will be measured in parts per billion (ppb) using the NIOX Mini device as a non-invasive marker of airway inflammation.
FeNO will be assessed using standardized procedures, and changes over time will be compared between the nutrition intervention and control groups.
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Baseline, approximately Week 6, and Week 12
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Change From Baseline in Hydrogen Peroxide (H₂O₂) Concentration in Exhaled Breath Condensate
時間枠：Baseline, approximately Week 6, and Week 12
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Hydrogen peroxide (H₂O₂) concentration in exhaled breath condensate (EBC) will be measured as a non-invasive marker of respiratory oxidative stress.
EBC will be collected using the RTube® collection system, and H₂O₂ concentration will be quantified using the Amplex™ Red Hydrogen Peroxide/Peroxidase Assay with fluorescence detection.
H₂O₂ concentrations will be reported in micromolar (µM) units.
Changes from baseline will be evaluated over the intervention period and compared between the nutrition intervention and control groups.
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Baseline, approximately Week 6, and Week 12
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Change From Baseline in Systolic Blood Pressure
時間枠：Baseline, approximately Week 6, and Week 12
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Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a validated automatic upper-arm blood pressure monitor.
Participants will obtain two measurements approximately one minute apart after at least five minutes of seated rest, and the average of the two measurements will be used for analysis.
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Baseline, approximately Week 6, and Week 12
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Change From Baseline in Diastolic Blood Pressure
時間枠：Baseline, approximately Week 6, and Week 12
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Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a validated automatic upper-arm blood pressure monitor.
Two measurements approximately one minute apart will be obtained after at least five minutes of seated rest, and the average will be used for analysis.
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Baseline, approximately Week 6, and Week 12
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Change From Baseline in Resting Heart Rate
時間枠：Baseline, approximately Week 6, and Week 12
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Resting heart rate will be measured in beats per minute (bpm) using a validated automatic upper-arm blood pressure monitor after the participant has rested quietly in a seated position for at least five minutes.
Two resting heart rate measurements will be obtained approximately one minute apart, and the mean of the two measurements will be used as the resting heart rate value for each assessment.
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Baseline, approximately Week 6, and Week 12
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Change From Baseline in Glycated Hemoglobin (HbA1c)
時間枠：Baseline and Week 12
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Glycated hemoglobin (HbA1c) will be measured using an FDA-cleared point-of-care finger-stick testing system as an exploratory marker of longer-term glycemic status.
HbA1c will be reported as a percentage.
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Baseline and Week 12
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Recruitment/Accrual Rate
時間枠：From initiation of recruitment through completion of study enrollment, approximately 6 months.
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Recruitment rate will be assessed as the proportion of individuals determined to be eligible for the study who enroll and complete the baseline assessment.
The recruitment rate will be calculated as the number of eligible individuals enrolled divided by the total number of eligible individuals approached/invited to participate, multiplied by 100.
Recruitment feasibility will be evaluated against a prespecified target of ≥70% enrollment of eligible individuals.
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From initiation of recruitment through completion of study enrollment, approximately 6 months.
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Adherence to the Food-Based Nutrition Intervention
時間枠：Throughout the 12-week intervention.
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Intervention adherence and fidelity will be evaluated among participants assigned to the nutrition intervention group.
Delivery fidelity will be assessed as the proportion of scheduled biweekly grocery deliveries successfully completed during the 12-week intervention.
Participant adherence will be assessed using study records and participant-reported consumption of the targeted foods provided through the intervention.
These measures will be used to determine whether the food-based nutrition intervention can be delivered as planned and followed by participants in preparation for a future larger-scale clinical trial.
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Throughout the 12-week intervention.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- H26382
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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