Air Pollution ExposureNCT07797413
Savannah Environmental Nutrition Study (SENS): Nutrition Intervention to Reduce Air Pollution-Related Airway Inflammation and Oxidative Stress
A study testing Antioxidant- and Nutrient-Rich Food-Based Nutrition Intervention in people with Air Pollution Exposure and Oxidative Stress, run by Georgia Southern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Air Pollution Exposure, Oxidative Stress, Airway Inflammation
- What is being tested?
- Antioxidant- and Nutrient-Rich Food-Based Nutrition Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Georgia Southern University and GROW Initiative GA
Savannah, Georgia, 31419
Atin Adhikari, PhD, (912) 4782289, aadhikari@georgiasouthern.edu
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Antioxidant- and Nutrient-Rich Food-Based Nutrition Intervention
- Keywords
- Air pollution, Nutrition intervention, Oxidative stress, Exhaled nitric oxide, FeNO, Exhaled breath condensate, Hydrogen peroxide, Particulate matter, Nitrogen dioxide, Ozone, Cardiometabolic health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant- and Nutrient-Rich Food-Based Nutrition InterventionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through Week 12.
Secondary outcomes (8)
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
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.
Measured: Baseline, approximately Week 6, and Week 12
Change From Baseline in Hydrogen Peroxide (H₂O₂) Concentration in Exhaled Breath Condensate
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.
Measured: Baseline, approximately Week 6, and Week 12
Change From Baseline in Systolic Blood Pressure
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.
Measured: Baseline, approximately Week 6, and Week 12
Change From Baseline in Diastolic Blood Pressure
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.
Measured: Baseline, approximately Week 6, and Week 12
Change From Baseline in Resting Heart Rate
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.
Measured: Baseline, approximately Week 6, and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c)
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.
Measured: Baseline and Week 12
Recruitment/Accrual Rate
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.
Measured: From initiation of recruitment through completion of study enrollment, approximately 6 months.
Adherence to the Food-Based Nutrition Intervention
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.
Measured: Throughout the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Pollution ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia Southern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atin Adhikari, Georgia Southern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797413
- Sponsor's protocol ID
- H26382
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data are not planned for external sharing because this is a small pilot community-based study and the combination of health, environmental exposure, and participant characteristics may increase the potential for participant re-identification. Aggregate study results will be disseminated through scientific presentations and peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07797413
- Acronym / sponsor ID
- H26382
- Keywords
- Air pollution, Nutrition intervention, Oxidative stress, Exhaled nitric oxide, FeNO, Exhaled breath condensate, Hydrogen peroxide, Particulate matter
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Georgia Southern UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nutrition Intervention | Experimental | Other: Antioxidant- and Nutrient-Rich Food-Based Nutrition InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidant- and Nutrient-Rich Food-Based Nutrition InterventionParticipants 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. | Other | Nutrition Intervention |
Primary outcome
Participant Retention Rate
Time frame: 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.
8 secondary outcomes
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline, approximately Week 6, and Week 12
Change From Baseline in Hydrogen Peroxide (H₂O₂) Concentration in Exhaled Breath Condensate
Time frame: Baseline, approximately Week 6, and Week 12
Change From Baseline in Systolic Blood Pressure
Time frame: Baseline, approximately Week 6, and Week 12
Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline, approximately Week 6, and Week 12
Change From Baseline in Resting Heart Rate
Time frame: Baseline, approximately Week 6, and Week 12
Change From Baseline in Glycated Hemoglobin (HbA1c)
Time frame: Baseline and Week 12
Recruitment/Accrual Rate
Time frame: From initiation of recruitment through completion of study enrollment, approximately 6 months.
Adherence to the Food-Based Nutrition Intervention
Time frame: Throughout the 12-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant-level data are not planned for external sharing because this is a small pilot community-based study and the combination of health, environmental exposure, and participant characteristics may increase the potential for participant re-identification. Aggregate study results will be disseminated through scientific presentations and peer-reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidant- and Nutrient-Rich Food-Based Nutrition Intervention in people with Air Pollution Exposure and Oxidative Stress, run by Georgia Southern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Atin Adhikari, PhD (912-478-2289, aadhikari@georgiasouthern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention Rate (time frame: Baseline through Week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.