Clinical trial NCT06390683: Biodiversity Interventions for Assisted Living Centers
Official title: Biodiversity Interventions for Well-Being - Research in Assisted Living Centers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nature, Human
Microbial Colonization
Well-Being, Psychological
Immune System and Related Disorders
Autism Spectrum Disorder
Visual Impairment
Keywords: Biodiversity
Well-being
Planetary health
Commensal microbiome
Immune system
Lead sponsor: Natural Resources Institute Finland
Sponsor class: OTHER_GOV
Collaborators: name: Tampere University
First posted: 2024-04-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 assisted living centers (BIWE 2), microbial biodiversity interventions are performed to increase biodiversity in urban housing units for people with autism spectrum disorder, disabled people and elderly. 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 yards of the housing units 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. The investigators will recruit approximately 36 study subjects living in assisted housing units in urban areas and aged between 18-82.

Eligibility criteria: Inclusion Criteria:

* Person lives in assisted living center

Exclusion Criteria:

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

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: Skin bacteria
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Saliva microbiota
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Saliva gene pathways
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: Changes in nature contacts
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
measure: Infectious diseases
timeFrame: Baseline, 3 month, 1 year, 2 year, 3 year, 4 year, 5 year
Other outcomes:
measure: Associations between environmental factors and primary and secondary outcomes
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: