Management of Occasional or Anticipatory Stress by Consumers of a Food Supplement

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Stress

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Food Supplement<br>Single dose of food Supplement Based on L-theanine, Passionflower and Rhodiola Extracts | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of level of felt stress before and after product intake | Change in stress VAS (visual analogue scale), minimum = 0 and maximum = 10 higher score means a worse outcome | Before and 20 minutes after product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of stress enhancement responders | Percentage of volunteers with a decrease in the VAS scale | Before and 20 minutes after product intake | 
| Evolution of level of felt stress | Change in stress VAS (visual analogue scale), minimum = 0 and maximum = 10 higher score means a worse outcome | stress usually felt, just before product intake, 20 minutes after product intake and before midnight | 
| Evolution of stress-related signs before and after product intake | Percentage of volunteers with a decrease in the stress-related signs VAS scales | Before and 20 minutes after product intake | 
| Percentage of stress-related signs enhancement responders | Percentage of volunteers with a decrease in the stress-related signs VAS scales | Before and 20 minutes after product intake | 
| EvaluatIon of the organoleptic properties | Evaluation with a Likert scale, minimum = very unpleasant and maximum = pleasant higher score means a best outcome | Before midnight | 
| satisfaction felt by volunteers | Evaluation with a Likert scale, minimum = not effective and maximum = very effective higher score means a best outcome | Before midnight | 
| Adverse events | Number and type of adverse events | Before midnight |