The Coastal Exposome: a Study of Sea Air Inhalation and Possible Links to Health

NCT06477627 | Active Not Recruiting

• 1 other identifier: ONZ-2024-0078
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Immune Suppression; Exposure

Keywords

Oceans and human health

Outcome Measures

Primary Outcomes (2)

• nose swabs: respiratory microbiome and biogenics profile

  DNA from the nose swabs will be analysed for microbiota and biogenics on the swabs will be analysed as well, to get an idea of what molecules and microbiota from the sea air are inhaled.

  4 times during the 8 week study period

• VAMS blood samples: cytokines

  Cytokines (IL-6, TNF-alfa, IL-10) will be measured in blood samples to link the sea air exposure to the human health

  4 times during the 8 week study period

Study Arms (3)

Studygroup that will move from inland to the coast for one month

OTHER

This group normally lives inland and live at the coast in august. We investigate the change to the coast environment

Other: change of environment

reference group coast

OTHER

This group lives inland the whole year round

Other: no intervention

reference group inland

OTHER

This group lives inland all year round.

Other: no intervention

Interventions

change of environment OTHER

The participants will change from inland to coastal environment to see the effect. We will take VAMS blood samples and nose swabs from the participant to measure this effect.

Studygroup that will move from inland to the coast for one month

no intervention OTHER

reference groups, stay in their coastal or inland environment

reference group coast; reference group inland

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• health participants between 18 and 50 years old

You may not qualify if:

• people with a medical condition
• people younger than 18 and older than 50

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Study Officials

• Hannelore Denys

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 in the month August lives at the coast (to investigate the change in environment) The participants will not get any treatment, they just have to give samples.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: June 19, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)