Difference Between Coastal and Inland PopulationsNCT06477627
The Coastal Exposome: a Study of Sea Air Inhalation and Possible Links to Health
A study of Difference Between Coastal and Inland Populations, run by University Ghent at 1 site in Belgium.
Trial summary
The research aims to understand oceans as crucial contributors to human health in coastal environments. Oceans produce marine spray aerosols that contain a mixture of microbiota and natural biological molecules (biogenics). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Difference Between Coastal and Inland Populations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jun 2024to 31 Oct 2026
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy participants between 18 and 50 years old
Who cannot join
- people with a medical condition
- people younger than 18 and older than 50
Trial locations and contacts
1 site in 1 country.
About this study
The research aims to understand oceans as crucial contributors to human health in coastal environments. Oceans produce marine spray aerosols that contain a mixture of microbiota and natural biological molecules (biogenics).
Read the detailed description
The primary outcome envisioned consists of 2 goals.
- In this study, the first objective is to determine whether the microbiota and biogenic molecules found in sea air are also found in the nasal swabs of the participants. In this way, the investigators will gain an understanding of which sea air components are inhaled by humans and how this changes over time. Besides, the difference in microbiome between the inland and coastal population will be investigated.
- Second, the investigators want to get an idea of whether these inhaled sea air components have an effect on certain pathways in the human body. In the in vitro study with cell lines, effects were already seen of sea air exposure on certain pathways in the body. Now the second goal of this study, is to see if changes in immunity biomarkers are seen in vivo in humans. The Investigators will do this by taking VAMS blood samples from the participants.
- Being tested
- no intervention
- Keywords
- Oceans and human health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, people just indicate if they spend time inland or at the coast
| Study group | Role | What they receive |
|---|---|---|
| group lives inland, but spends a lot of time at the coast during study period | Other | This group lives inland, but spends a lot of time at the coast during the study period. Receives: Other: no intervention |
| reference group coast | Other | This group lives at the coast the whole year round Receives: Other: no intervention |
| reference group inland | Other | This group lives inland all year round. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
nose swabs: respiratory microbiome and biogenics profile
DNA from the nose swabs will be analysed using sequencing for analyzing the microbiome. Biogenics on the swabs will be analysed as well, to get an idea of what molecules and microbiota from the sea air are inhaled. This will happen with UPLC-QTOF-MS.
Measured: 4 times during the 8 week study period
VAMS blood samples: cytokines
Cytokines will be measured in blood samples to link the sea air exposure to the human health. A multiplex kit will be used to measure 20 cytokines.
Measured: 4 times during the 8 week study period
GPS
via sensorlogger app on their phone, to collect GPS data when outside.
Measured: during the 8 week study period, if more than 15 minutes spend outside
questionnaires
Filling in a questionnaire via qualtrics
Measured: at the start, in the middle and at the end of the 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start19 Jun 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difference Between Coastal and Inland PopulationsStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- three groups: one group that lives at the coast all year round, one group that lives inland all year round and one group that live inland but spend a lot of time at the coast in the summer. The participants will not get any treatment, they just live in different regions.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannelore Denys, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477627
- Sponsor's protocol ID
- ONZ-2024-0078
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Coastal Exposome: a Study of Sea Air Inhalation and Possible Links to Health
- ClinicalTrials.gov ID
- NCT06477627
- Acronym / sponsor ID
- ONZ-2024-0078
- Keywords
- Oceans and human health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 27 Jun 2024 (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.
The research aims to understand oceans as crucial contributors to human health in coastal environments. Oceans produce marine spray aerosols that contain a mixture of microbiota and natural biological molecules (biogenics).
Detailed description
The primary outcome envisioned consists of 2 goals.
- In this study, the first objective is to determine whether the microbiota and biogenic molecules found in sea air are also found in the nasal swabs of the participants. In this way, the investigators will gain an understanding of which sea air components are inhaled by humans and how this changes over time. Besides, the difference in microbiome between the inland and coastal population will be investigated.
- Second, the investigators want to get an idea of whether these inhaled sea air components have an effect on certain pathways in the human body. In the in vitro study with cell lines, effects were already seen of sea air exposure on certain pathways in the body. Now the second goal of this study, is to see if changes in immunity biomarkers are seen in vivo in humans. The Investigators will do this by taking VAMS blood samples from the participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- three groups: one group that lives at the coast all year round, one group that lives inland all year round and one group that live inland but spend a lot of time at the coast in the summer. The participants will not get any treatment, they just live in different regions.
| Arm | Type | Receives |
|---|---|---|
| group lives inland, but spends a lot of time at the coast during study period | Other | Other: no interventionThis group lives inland, but spends a lot of time at the coast during the study period. |
| reference group coast | Other | Other: no interventionThis group lives at the coast the whole year round |
| reference group inland | Other | Other: no interventionThis group lives inland all year round. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy participants between 18 and 50 years old
Key exclusion criteria (2 listed)
- people with a medical condition
- people younger than 18 and older than 50
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 |
|---|---|---|
| no interventionno intervention, people just indicate if they spend time inland or at the coast | Other | group lives inland, but spends a lot of time at the coast during study period, reference group coast, reference group inland |
Primary outcome
nose swabs: respiratory microbiome and biogenics profile
Time frame: 4 times during the 8 week study period
DNA from the nose swabs will be analysed using sequencing for analyzing the microbiome. Biogenics on the swabs will be analysed as well, to get an idea of what molecules and microbiota from the sea air are inhaled. This will happen with UPLC-QTOF-MS.
VAMS blood samples: cytokines
Time frame: 4 times during the 8 week study period
Cytokines will be measured in blood samples to link the sea air exposure to the human health. A multiplex kit will be used to measure 20 cytokines.
GPS
Time frame: during the 8 week study period, if more than 15 minutes spend outside
via sensorlogger app on their phone, to collect GPS data when outside.
questionnaires
Time frame: at the start, in the middle and at the end of the 8 weeks.
Filling in a questionnaire via qualtrics
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Hannelore Denys principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Difference Between Coastal and Inland Populations, run by University Ghent at 1 site in Belgium.
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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nose swabs: respiratory microbiome and biogenics profile (time frame: 4 times during the 8 week study period). The study lists 4 primary outcomes in all. 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 3 Jun 2026.