NCT07678528

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Sep 2030

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
4.2 years until next milestone

Study Start

First participant enrolled

September 1, 2030

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 11, 2026

Last Update Submit

June 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    at baseline and 12 months later

Secondary Outcomes (16)

  • Functional and health status

    at baseline and 1 year

  • Physical functional capacities (health measure)

    at baseline and at 12 months

  • Quality of life (health measure)

    at baseline and 12 months

  • Autonomy (health measure)

    at baseline and 12 months

  • Comorbidity (health measure)

    at baseline and 12 months

  • +11 more secondary outcomes

Study Arms (1)

Exposome assessment

OTHER
Other: Exposome assessment

Interventions

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

Exposome assessment

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients currently undergoing intensive drug treatment, including chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice - Hopital de Cimiez

Nice, France

Location

Central Study Contacts

Olivier GUERIN, PROFESSOR

CONTACT

Virginie PIOVANO

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

July 1, 2026

Study Start (Estimated)

September 1, 2030

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

September 1, 2031

Last Updated

July 1, 2026

Record last verified: 2026-06

Locations