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NCT Number: NCT07678528

Exposome, Pollutants, Biology in the Older Subject: EXPOSAGE

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.

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Key information

Conditions

Aging Disorder

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Hopital de Cimiez

Nice, France

Location contact

Olivier GUERIN, Pr

CONTACT

[email protected]

0492034194

Olivier GUERIN, Pr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exposome assessment

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional and health status

    Time frame: at baseline and 1 year

    Disease presence : : Presence (yes/no) of chronic disease

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. DNA and telomere damage (internal exposome/biological measure)

    Time frame: at baseline.

    DNA damage will be obtained through epigenetic analysis by studying miRNAs.

  8. 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))

  9. 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.

  10. Smoking habits (external personal exposome measure)

    Time frame: at baseline.

    smoking/non-smoking status identified via questionnaire.

  11. Alcohol habits (external personal exposome measure)

    Time frame: at baseline

    consumption volume identified via questionnaire.

  12. Self-reported physical activity habits (external personal exposome measure)

    Time frame: at baseline

    volume of physical activity practice over a week identified via questionnaire.

  13. Objective-measured physical activity habits (external personal exposome measure)

    Time frame: at baseline

    volume of physical activity practice over a week identified via actigraphy.

  14. Socioeconomic characteristic (external personal exposome measure)

    Time frame: at baseline

    level of study identified via questionnaire.

  15. Socioeconomic characteristic (external personal exposome measure)

    Time frame: at baseline

    socio-professional category identified via questionnaire.

  16. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier GUERIN, PROFESSOR

CONTACT

[email protected]

0492034194

Virginie PIOVANO

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: EXPOSAGE

Important dates

Study start
2030
Primary completion
2031
Study completion
2031
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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