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Not yet recruiting NCT07678528

Exposome, Pollutants, Biology in the Older Subject: EXPOSAGE

No phase Interventional Aging Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exposome assessment.
Who it may be relevant to
Registry conditions: Aging Disorder. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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

Primary outcome measures

  • Frailty (health measure) [Time frame: at baseline and 12 months later]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Nice - Hopital de Cimiez — Nice

Identifiers

NCT: NCT07678528 · 25-PP-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗