NCT07320040

Brief Summary

Recent studies show that emotional states can be discriminated by physiological responses. This physiological regulation results from the action of enzymes and hormones that represent the activity of the autonomic nervous system. The measurement of specific biomarkers, using non-invasive biological tests in saliva, would therefore provide physiological data on an individual's emotional state in response to stimuli, particularly olfactory stimuli.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress76%
Nov 2022Jun 2027

Study Start

First participant enrolled

November 14, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2027

Expected
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 19, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

BiomarkersStimuliRelated

Outcome Measures

Primary Outcomes (1)

  • Evaluate variations

    Evaluate variations in several molecular biomarkers in saliva following fragrance stimulus/stimuli that may be linked to an emotionnal response (positive or negative).

    1 year

Secondary Outcomes (5)

  • Identify a molecular biomarker signature

    2 years

  • Evaluate basal values of biomarkers

    3 years

  • Evaluate signature dynamics

    1 year

  • Establish correlations between biomarker signatures and emotion ratings

    3 years

  • Compare biomarker signatures

    2 years

Study Arms (2)

Bras S Fragrance then placebo

Subjects will be subjected successively to fragrance and placebo stimulation.

Other: Identication and measurement of a molecular biomarkers signature

Bras P Placebo then fragrance

Subjects will be subjected successively to placebo and fragrance stimulation.

Other: Identication and measurement of a molecular biomarkers signature

Interventions

Levels of the biomarkers of interest (DHEA, pg/mL; Oxytocin, pg/mL; Cortisol, pg/mL; Alpha Amylase, U/mL) will be measured in the saliva of participating subjects by enzymatic assay methods or ELISA-type methods performed using commercial kits.

Bras P Placebo then fragranceBras S Fragrance then placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population for this study will consist of healthy volunteers who meet the eligibility criteria.

You may qualify if:

  • Subject willing to follow study procedures
  • Subject able to understand the purpose, nature and methodology of the study
  • Subject has signed informed consent form
  • Subjects between 18 and 60 years of age.

You may not qualify if:

  • Subjects deprived of liberty, protected adults, vulnerable persons or minors
  • Subjects with a proven or suspected chronic infectious disease that could entail a risk of contamination during sample handling (laboratories not equipped to handle this type of sample)
  • Rejection to sign the consent form.
  • Pregnant or breastfeeding women
  • Subjects presenting anosmia during the last 15 days
  • Subjects presenting symptoms and signs of active oral inflammation, advanced periodontitis or severe gingivitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SYS2DIAG - UMR9005 CNRS/ALCEN, Montpellier, 34184

Montpellier, France

RECRUITING

Related Publications (1)

  • Giacomello G, Scholten A, Parr MK. Current methods for stress marker detection in saliva. J Pharm Biomed Anal. 2020 Nov 30;191:113604. doi: 10.1016/j.jpba.2020.113604. Epub 2020 Sep 6.

    PMID: 32957066BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

Study Officials

  • Laurence MOLINA, Phd

    Sys2Diag

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 6, 2026

Study Start

November 14, 2022

Primary Completion

March 14, 2023

Study Completion (Estimated)

June 14, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations