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

Larena SAS113 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

113

Conditions

Stress

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Cen Experimental

Dijon, France

Outcomes

Primary Outcomes

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

Time frame: Before and 20 minutes after product intake

Secondary Outcomes

Percentage of stress enhancement responders

Percentage of volunteers with a decrease in the VAS scale

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Before midnight

satisfaction felt by volunteers

Evaluation with a Likert scale, minimum = not effective and maximum = very effective higher score means a best outcome

Data from ClinicalTrials.gov

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