Clinical trial NCT06353035: Biodiversity Interventions for Well-Being
Official title: Biodiversity Interventions for Well-being, Neighborhood Rewilding
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Microbial Colonization
Immune System Diseases
Well-Being, Psychological
Nature, Human
Keywords: Commensal microbiome
Salivary cytokines
Planetary health
Well-being
Lead sponsor: Natural Resources Institute Finland
Sponsor class: OTHER_GOV
Collaborators: name: Tampere University
First posted: 2024-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment.
Primary purpose: BASIC_SCIENCE

Brief summary: Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.

In Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.

The investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways.

Detailed description: Our specific aims are:

To assess if rewilding diversifies health-associated skin microbiota and is associated with salivary cytokine levels, gene pathways, cortisol levels and commensal microbiota.

Assess whether there are patterns in the microbiome associated with the salivary cytokine levels and hair cortisol levels.

Assess whether rewilding affects health and psychological measures, such as Perceived Stress Scale (PSS), Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), Depression Scale (DEPS) and Nature Relatedness Scale (NR6).

The investigators will recruit approximately 42 (21 study subjects per treatment) subjects living in a detached house or terraced house in urban areas and aged between 18-72.

The medical exclusion criteria include immunosuppressive medications, immune deficiencies, a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes), cancer diagnosis within the last year or on-going cancer treatment. Other exclusion criteria include incompetency and living outside city area.

Eligibility criteria: Inclusion Criteria:

* Living in a detached or terraced house in urban area

Exclusion Criteria:

* Immunosuppressive medications
* Immune deficiencies
* a disease affecting immune response (e.g., colitis ulcerosa, rheumatoid arthritis, Crohn's disease, diabetes)
* cancer diagnosis within the last year or on-going cancer treatment
* Incompetency
* Living outside city area.

Primary outcomes:
measure: Skin Gammaproteobacteria
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Secondary outcomes:
measure: Salivary cytokines
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Difference in observed species richness of skin, saliva and stool microbiota
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Difference in taxonomies of skin, saliva and stool microbiota
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Difference in microbial gene pathways of saliva and stool microbiota
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Cortisol levels
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Perceived Stress Scale
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Depression Scale
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Nature Relatedness Scale
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Metabolites in urine
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Other outcomes:
measure: Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Locations:
city: Helsinki
country: Finland
facility: Natural Resources Institute Finland
state: Uusimaa
Study officials:
affiliation: Natural Resources Institute Finland
name: Aki Sinkkonen
role: PRINCIPAL_INVESTIGATOR
References: