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Exposome, Pollutants, Biology in the Older Subject: EXPOSAGE

Exposome, Pollutants, Biology in the Older Subject: EXPOSAGE

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07678528
Acronym
EXPOSAGE
Enrollment
400
Registered
2026-07-01
Start date
2030-09-01
Completion date
2031-09-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging Disorder

Brief summary

Numerous factors, both individual and environmental, can influence aging, an individual's health, and their functional status. However, the understanding of the combined impact of lifestyle-related exposures (e.g., physical activity, diet, sleep) (personal external exposome), exposures to pollutants (environmental external exposome), and their biological responses (internal exposome)-in other words, the impact of the "exposome" on healthy aging-remains limited, particularly in characterizing the molecular mechanisms associated with these interactions. Exposome approaches identifying key exposures and molecular mechanisms could lead to a better understanding of how the environment, interacting with health behaviors, can affect functional status. Thus, the objective of this study is i) to evaluate the links between the external exposome, the internal exposome and the health of older and aging individuals, and ii) to identify biological markers associated with a vulnerable health status in older and aging individuals.

Interventions

OTHERExposome assessment

Visit 1: blood sample, questionnaires on the personal exposome (lifestyle habits (e.g., physical activity, diet, stress) and social characteristics and health status) \| ii) Outpatient assessment: wearing a silicone bracelet for 7 days to measure external environmental exposure to pollutants and quantify physical activity \| iii) Visit 2: 1-year follow-up of health status

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Aged 55 or over * Affiliated with or beneficiaries of a social security scheme * Signed the informed consent form •-Persons residing in one of the following municipalities : Antibes, Le Bar-sur-Loup, Berre-les-Alpes, Beuil, Blausasc, Breil-sur-Roya, Cabris, Cannes, Carros, Clans, Contes, Drap, L'Escarène, Escragnolles, Fontan, La Gaude, Gilette, Grasse, Lantosque, Levens, Nice, Peillon, Peymeinade, Saint-André-de-la-Roche, Saint-Etienne-de-Tinée, Sospel, Tourrettes-sur-Loup, Vence, Tende

Exclusion criteria

* patients currently undergoing intensive drug treatment, including chemotherapy

Design outcomes

Primary

MeasureTime frameDescription
Frailty (health measure)at baseline and 12 months laterFrailty is assessed using the Groningen Frailty Indicator. The scale comprises 15 items. The total score ranges from 0 to 25, with a higher score being worse.

Secondary

MeasureTime frameDescription
Functional and health statusat baseline and 1 yearDisease presence : : Presence (yes/no) of chronic disease
Physical functional capacities (health measure)at baseline and at 12 monthsPhysical functional capacities are assessed using the Short Physical Performance Battery which assess balance, walking capacities and strength via a sit to stand test
Quality of life (health measure)at baseline and 12 monthsQuality of life is assessed using the SF-12 questionnaire. The scale comprises 12 items.
Autonomy (health measure)at baseline and 12 monthsAutonomy is assessed using the WHOQOL-OLD-AUT questionnaire. The scale comprises 4 items. The total score ranges from 4 to 20, with a higher score being better.
Comorbidity (health measure)at baseline and 12 monthsComorbidity is assessed using the Charlson Index which counts the number of comorbidities. Higher score means greater number of comorbidities and therefore a poorer health.
Pollutant metabolites (internal exposome/biological measure)at baseline.Presence in the blood metabolome of molecules directly associated with pollutants (initial or biotransformed compounds). This outcome will be obtained through a metabolomic analysis by very high-resolution mass spectrometry (consisting of the analysis of all small organic molecules (or metabolites)) performed on blood samples taken by a blood sampling.
DNA and telomere damage (internal exposome/biological measure)at baseline.DNA damage will be obtained through epigenetic analysis by studying miRNAs.
exposure to air pollutants (external environmental exposome measure)at baselinecharacteristics in terms of air pollution of the living space (quantity of fine particulate matter (PM), ozone (O3), nitrogen dioxide (NO2), or sulfur dioxide (SO2))
exposure to pesticides, hydrocarbons, plastics, flame retardant pollutants (external environmental exposome measure)at baselinethe exposure will be obtained through a silicone bracelet worn for 7 days by the participant, which will allow the measure of all exposures in the person's daily life.
Smoking habits (external personal exposome measure)at baseline.smoking/non-smoking status identified via questionnaire.
Alcohol habits (external personal exposome measure)at baselineconsumption volume identified via questionnaire.
Self-reported physical activity habits (external personal exposome measure)at baselinevolume of physical activity practice over a week identified via questionnaire.
Objective-measured physical activity habits (external personal exposome measure)at baselinevolume of physical activity practice over a week identified via actigraphy.
Socioeconomic characteristic (external personal exposome measure)at baselinelevel of study identified via questionnaire.
Psychological health (external personal exposome measure)at baselineanxiety assessed using the Hospital Anxiety and Depression Scale (HAD). The scale comprises 14 items. The total score ranges from 0 to 21, with a higher score being worse.

Countries

France

Contacts

CONTACTOlivier GUERIN, PROFESSOR
guerin.o@chu-nice.fr0492034194
CONTACTVirginie PIOVANO
piovano.v@chu-nice.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026