Evaluation of Emotion-related Salivary Molecular Biomarkers
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: Identication and measurement of a molecular biomarkers signature.
- Who it may be relevant to
- Registry conditions: Emotion. Basic parameters: 18 years — 60 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 →
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Official title
Evaluation of Emotion-related Salivary Molecular Biomarkers Following Olfactory Stimuli
Overview
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.
Detailed description
Recent studies show that emotional states (positive and negative) can be discriminated by physiological responses. This physiological regulation stems from the action of enzymes and hormones that represent the activity of the autonomic nervous system. The measurement of specific biomarkers (enzymes, hormones), using non-invasive biological tests in saliva, would therefore provide physiological data on an individual's emotional state (Giacomello et al. 2020) in response to stimuli, particularly olfactory stimuli.
The aim of the proposed research is to identify and measure a signature of molecular biomarkers in saliva, linked to emotions following one or more olfactory stimuli (e.g. cortisol and alpha-amylase concentration increase after stimulation).
Interventions
- Other Identication and measurement of a molecular biomarkers signature
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.
Primary outcome measures
- Evaluate variations [Time frame: 1 year]
Secondary outcome measures (5)
- Identify a molecular biomarker signature [Time frame: 2 years]
- Evaluate basal values of biomarkers [Time frame: 3 years]
- Evaluate signature dynamics [Time frame: 1 year]
- Establish correlations between biomarker signatures and emotion ratings [Time frame: 3 years]
- Compare biomarker signatures [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Non specific inclusion criteria:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- SYS2DIAG - UMR9005 CNRS/ALCEN, Montpellier, 34184 — Montpellier
Publications
- 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 32957066
Identifiers
NCT: NCT07320040 · 2022-A02008-35 · 22.03698.000189