Clinical trial NCT05830565: Management of Occasional or Anticipatory Stress by Consumers of a Food Supplement
Official title: Survey on the Management of Occasional or Anticipatory Stress by Consumers of a Food Supplement Based on L-theanine, Passionflower and Rhodiola Extracts and Satisfaction With This Supplementation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Lead sponsor: Larena SAS
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult believing that they could be exposed to a stressful event in the next 2 months

Brief summary: Volunteers will fill out an initial questionnaire which will describe their current situation, their pathologies and current treatments, their medical history.

Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.

Detailed description: Participants in the survey will come from a panel of volunteers. They will be contacted via an email proposing the survey accompanied by a selection questionnaire. Eligible volunteers will be called by the clinical investigation center to confirm their participation.

Volunteers will fill out an initial questionnaire which will describe their current situation (sex, age, family and professional situation, cigarette consumption), their pathologies and current treatments, their medical history (disorders related to sleep, stress, anxiety, burnout, depression or other mental disorders).

Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.

Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years old)
* PSS Questionnaire (Perceived Stress Scale) ≥ 14
* Believing that they could be exposed to a stressful event in the next 2 months

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Currently taking a treatment from the following list: antihypertensives, immunosuppressants, antidepressants/barbiturates, anxiolytics, vitamin K antagonists (warfarin, acenocoumarol, fluindione), miconazole, anticonvulsants (carbamazepine, phenobarbital, phenytoin, oxcarbazepine...) and/or anti -infectious (rifampicin, rifabutin, efavirenz, nevirapine, griseofulvin)
* With diabetes, autoimmune disease or hypotension
* Currently taking a medication or dietary supplement that may affect mood, stress, sleep or anxiety
* Currently using products containing any of the following ingredients: hawthorn, ashwagandha (Withania somnifera), bacopa monnieri, black grass, holy basil (Ocimum sanctum), fig buds, CBD, Eleutherococcus, Eschscholtzia, ginseng, griffonia, hops, oil lavender essential oil, marjoram essential oil, lavender hydrolyzate, milk protein hydrolyzate (Lactium), inositol, magnesium, lemon balm, St. John's wort, angelica orange, passionflower, rhodiola, saffron, theanine, asparagus stalk, tryptophan, valerian
* Having known allergies to the ingredients of the product (theanine, rhodiola, passionflower and lavender)

Primary outcomes:
measure: Evolution of level of felt stress before and after product intake
timeFrame: Before and 20 minutes after product intake
Secondary outcomes:
measure: Percentage of stress enhancement responders
timeFrame: Before and 20 minutes after product intake
measure: Evolution of level of felt stress
timeFrame: stress usually felt, just before product intake, 20 minutes after product intake and before midnight
measure: Evolution of stress-related signs before and after product intake
timeFrame: Before and 20 minutes after product intake
measure: Percentage of stress-related signs enhancement responders
timeFrame: Before and 20 minutes after product intake
measure: EvaluatIon of the organoleptic properties
timeFrame: Before midnight
measure: satisfaction felt by volunteers
timeFrame: Before midnight
measure: Adverse events
timeFrame: Before midnight
Other outcomes:
Locations:
city: Dijon
country: France
facility: Cen Experimental
Study officials:
affiliation: CEN
name: Carole Perrin
role: PRINCIPAL_INVESTIGATOR
References: