Stress
Conditions
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.
Interventions
None listed
Sponsors
Larena SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of level of felt stress before and after product intake | Before and 20 minutes after product intake | Change in stress VAS (visual analogue scale), minimum = 0 and maximum = 10 higher score means a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of level of felt stress | stress usually felt, just before product intake, 20 minutes after product intake and before midnight | Change in stress VAS (visual analogue scale), minimum = 0 and maximum = 10 higher score means a worse outcome |
| Evolution of stress-related signs before and after product intake | Before and 20 minutes after product intake | Percentage of volunteers with a decrease in the stress-related signs VAS scales |
| Percentage of stress-related signs enhancement responders | Before and 20 minutes after product intake | Percentage of volunteers with a decrease in the stress-related signs VAS scales |
| Percentage of stress enhancement responders | Before and 20 minutes after product intake | Percentage of volunteers with a decrease in the VAS scale |
| satisfaction felt by volunteers | Before midnight | Evaluation with a Likert scale, minimum = not effective and maximum = very effective higher score means a best outcome |
| Adverse events | Before midnight | Number and type of adverse events |
| EvaluatIon of the organoleptic properties | Before midnight | Evaluation with a Likert scale, minimum = very unpleasant and maximum = pleasant higher score means a best outcome |
Countries
France
Outcome results
None listed