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

Not Applicable

Active, not recruiting

• Conditions: Immune Suppression; Exposure

• Registration Number: NCT06477627
• Lead Sponsor: University Ghent

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).

Detailed Description

The primary outcome envisioned consists of 2 goals.

1. 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.

2. 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 (IL-6, TNF-alpha, IL-10) are seen in vivo in humans. The Investigators will do this by taking VAMS blood samples from the participants.

Study Timeline

• Study Start: 2024-06-19
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• health participants between 18 and 50 years old

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAMS blood samples: cytokines	4 times during the 8 week study period	Cytokines (IL-6, TNF-alfa, IL-10) will be measured in blood samples to link the sea air exposure to the human health
nose swabs: respiratory microbiome and biogenics profile	4 times during the 8 week study period	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.

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, Oost-Vlaanderen, Belgium