- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07678528
Exposome, Pollutants, Biology in the Older Subject: EXPOSAGE (EXPOSAGE)
June 24, 2026 updated by: Centre Hospitalier Universitaire de Nice
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Virginie PIOVANO
- Email: piovano.v@chu-nice.fr
Study Contact Backup
- Name: Olivier GUERIN, PROFESSOR
- Phone Number: 0492034194
- Email: guerin.o@chu-nice.fr
Study Locations
-
-
-
Nice, France
- CHU de Nice - Hopital de Cimiez
-
Principal Investigator:
- Olivier GUERIN, Pr
-
Contact:
- Olivier GUERIN, Pr
- Phone Number: 0492034194
- Email: guerin.o@chu-nice.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Exposome 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty (health measure)
Time Frame: at baseline and 12 months later
|
Frailty 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.
|
at baseline and 12 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional and health status
Time Frame: at baseline and 1 year
|
Disease presence : : Presence (yes/no) of chronic disease
|
at baseline and 1 year
|
|
Physical functional capacities (health measure)
Time Frame: at baseline and at 12 months
|
Physical functional capacities are assessed using the Short Physical Performance Battery which assess balance, walking capacities and strength via a sit to stand test
|
at baseline and at 12 months
|
|
Quality of life (health measure)
Time Frame: at baseline and 12 months
|
Quality of life is assessed using the SF-12 questionnaire.
The scale comprises 12 items.
|
at baseline and 12 months
|
|
Autonomy (health measure)
Time Frame: at baseline and 12 months
|
Autonomy 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.
|
at baseline and 12 months
|
|
Comorbidity (health measure)
Time Frame: at baseline and 12 months
|
Comorbidity is assessed using the Charlson Index which counts the number of comorbidities.
Higher score means greater number of comorbidities and therefore a poorer health.
|
at baseline and 12 months
|
|
Pollutant metabolites (internal exposome/biological measure)
Time Frame: 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.
|
at baseline.
|
|
DNA and telomere damage (internal exposome/biological measure)
Time Frame: at baseline.
|
DNA damage will be obtained through epigenetic analysis by studying miRNAs.
|
at baseline.
|
|
exposure to air pollutants (external environmental exposome measure)
Time Frame: at baseline
|
characteristics in terms of air pollution of the living space (quantity of fine particulate matter (PM), ozone (O3), nitrogen dioxide (NO2), or sulfur dioxide (SO2))
|
at baseline
|
|
exposure to pesticides, hydrocarbons, plastics, flame retardant pollutants (external environmental exposome measure)
Time Frame: at baseline
|
the 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.
|
at baseline
|
|
Smoking habits (external personal exposome measure)
Time Frame: at baseline.
|
smoking/non-smoking status identified via questionnaire.
|
at baseline.
|
|
Alcohol habits (external personal exposome measure)
Time Frame: at baseline
|
consumption volume identified via questionnaire.
|
at baseline
|
|
Self-reported physical activity habits (external personal exposome measure)
Time Frame: at baseline
|
volume of physical activity practice over a week identified via questionnaire.
|
at baseline
|
|
Objective-measured physical activity habits (external personal exposome measure)
Time Frame: at baseline
|
volume of physical activity practice over a week identified via actigraphy.
|
at baseline
|
|
Socioeconomic characteristic (external personal exposome measure)
Time Frame: at baseline
|
level of study identified via questionnaire.
|
at baseline
|
|
Socioeconomic characteristic (external personal exposome measure)
Time Frame: at baseline
|
socio-professional category identified via questionnaire.
|
at baseline
|
|
Psychological health (external personal exposome measure)
Time Frame: at baseline
|
anxiety 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.
|
at baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2030
Primary Completion (Estimated)
September 1, 2031
Study Completion (Estimated)
September 1, 2031
Study Registration Dates
First Submitted
June 11, 2026
First Submitted That Met QC Criteria
June 24, 2026
First Posted (Actual)
July 1, 2026
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 24, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 25-PP-25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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