Aging DisorderEXPOSAGENCT07678528
Exposome, Pollutants, Biology in the Older Subject: EXPOSAGE
A study testing Exposome assessment in people with Aging Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Disorder
- What is being tested?
- Exposome assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2030to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients currently undergoing intensive drug treatment, including chemotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Virginie PIOVANO contact
France1 site
CHU de Nice - Hopital de Cimiez
Nice
Olivier GUERIN, Pr, 0492034194, guerin.o@chu-nice.fr
Olivier GUERIN, Pr
About this study
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.
- Conditions
- Aging Disorder
- Being tested
- Exposome assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposome assessmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Exposome assessment | Other | Not described Receives: Other: Exposome assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty (health measure)
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.
Measured: at baseline and 12 months later
Secondary outcomes (16)
Functional and health status
Disease presence : : Presence (yes/no) of chronic disease
Measured: at baseline and 1 year
Physical functional capacities (health measure)
Physical functional capacities are assessed using the Short Physical Performance Battery which assess balance, walking capacities and strength via a sit to stand test
Measured: at baseline and at 12 months
Quality of life (health measure)
Quality of life is assessed using the SF-12 questionnaire. The scale comprises 12 items.
Measured: at baseline and 12 months
Autonomy (health measure)
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.
Measured: at baseline and 12 months
Comorbidity (health measure)
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.
Measured: at baseline and 12 months
Pollutant metabolites (internal exposome/biological measure)
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.
Measured: at baseline.
DNA and telomere damage (internal exposome/biological measure)
DNA damage will be obtained through epigenetic analysis by studying miRNAs.
Measured: at baseline.
exposure to air pollutants (external environmental exposome measure)
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))
Measured: at baseline
exposure to pesticides, hydrocarbons, plastics, flame retardant pollutants (external environmental exposome measure)
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.
Measured: at baseline
Smoking habits (external personal exposome measure)
smoking/non-smoking status identified via questionnaire.
Measured: at baseline.
Alcohol habits (external personal exposome measure)
consumption volume identified via questionnaire.
Measured: at baseline
Self-reported physical activity habits (external personal exposome measure)
volume of physical activity practice over a week identified via questionnaire.
Measured: at baseline
Objective-measured physical activity habits (external personal exposome measure)
volume of physical activity practice over a week identified via actigraphy.
Measured: at baseline
Socioeconomic characteristic (external personal exposome measure)
level of study identified via questionnaire.
Measured: at baseline
Socioeconomic characteristic (external personal exposome measure)
socio-professional category identified via questionnaire.
Measured: at baseline
Psychological health (external personal exposome measure)
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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startSep 2030 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678528
- Sponsor's protocol ID
- 25-PP-25
- Acronym
- EXPOSAGE
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposome, Pollutants, Biology in the Older Subject: EXPOSAGE
- ClinicalTrials.gov ID
- NCT07678528
- Acronym / sponsor ID
- EXPOSAGE / 25-PP-25
- Conditions
- Aging Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Sep 2030 (estimated)
- Primary completion
- Sep 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposome assessment | Other | Other: Exposome assessment |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- patients currently undergoing intensive drug treatment, including chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposome assessmentVisit 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 | Other | Exposome assessment |
Primary outcome
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.
16 secondary outcomes
Functional and health status
Time frame: at baseline and 1 year
Physical functional capacities (health measure)
Time frame: at baseline and at 12 months
Quality of life (health measure)
Time frame: at baseline and 12 months
Autonomy (health measure)
Time frame: at baseline and 12 months
Comorbidity (health measure)
Time frame: at baseline and 12 months
Pollutant metabolites (internal exposome/biological measure)
Time frame: at baseline.
DNA and telomere damage (internal exposome/biological measure)
Time frame: at baseline.
exposure to air pollutants (external environmental exposome measure)
Time frame: at baseline
exposure to pesticides, hydrocarbons, plastics, flame retardant pollutants (external environmental exposome measure)
Time frame: at baseline
Smoking habits (external personal exposome measure)
Time frame: at baseline.
Alcohol habits (external personal exposome measure)
Time frame: at baseline
Self-reported physical activity habits (external personal exposome measure)
Time frame: at baseline
Objective-measured physical activity habits (external personal exposome measure)
Time frame: at baseline
Socioeconomic characteristic (external personal exposome measure)
Time frame: at baseline
Socioeconomic characteristic (external personal exposome measure)
Time frame: at baseline
Psychological health (external personal exposome measure)
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginie PIOVANO contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposome assessment in people with Aging Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier GUERIN, PROFESSOR (0492034194, guerin.o@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (health measure) (time frame: at baseline and 12 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.