NCT06477627

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jun 2024Oct 2026

Study Start

First participant enrolled

June 19, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 21, 2024

Last Update Submit

June 1, 2026

Conditions

Keywords

Oceans and human health

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    4 times during the 8 week study period

  • GPS

    via sensorlogger app on their phone, to collect GPS data when outside.

    during the 8 week study period, if more than 15 minutes spend outside

  • questionnaires

    Filling in a questionnaire via qualtrics

    at the start, in the middle and at the end of the 8 weeks.

Study Arms (3)

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.

Other: no intervention

reference group coast

OTHER

This group lives at the coast the whole year round

Other: no intervention

reference group inland

OTHER

This group lives inland all year round.

Other: no intervention

Interventions

no intervention, people just indicate if they spend time inland or at the coast

group lives inland, but spends a lot of time at the coast during study periodreference group coastreference group inland

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
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 spend a lot of time at the coast in the summer. The participants will not get any treatment, they just live in different regions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 27, 2024

Study Start

June 19, 2024

Primary Completion

October 31, 2024

Study Completion (Estimated)

October 31, 2026

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations