Management of Occasional or Anticipatory Stress by Consumers of a Food Supplement (MELIM)

Larena SAS

Status: Completed

Conditions: Stress

Study type: Observational

Funder types: Industry

Identifiers

NCT05830565

PIL-RIPH3-MELIM-023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

113 participants in 1 patient group

Food Supplement

Description:

Single dose of food Supplement Based on L-theanine, Passionflower and Rhodiola Extracts