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OpenTrials
Completed

NCT Number: NCT05830565

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cen Experimental

Dijon, 21000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Evolution of level of felt stress before and after product intake

    Time frame: 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 outcomes

  1. Percentage of stress enhancement responders

    Time frame: Before and 20 minutes after product intake

    Percentage of volunteers with a decrease in the VAS scale

  2. Evolution of level of felt stress

    Time frame: 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

  3. Evolution of stress-related signs before and after product intake

    Time frame: Before and 20 minutes after product intake

    Percentage of volunteers with a decrease in the stress-related signs VAS scales

  4. Percentage of stress-related signs enhancement responders

    Time frame: Before and 20 minutes after product intake

    Percentage of volunteers with a decrease in the stress-related signs VAS scales

  5. EvaluatIon of the organoleptic properties

    Time frame: Before midnight

    Evaluation with a Likert scale, minimum = very unpleasant and maximum = pleasant higher score means a best outcome

  6. satisfaction felt by volunteers

    Time frame: Before midnight

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

  7. Adverse events

    Time frame: Before midnight

    Number and type of adverse events

Sponsors and collaborators

Lead sponsor

Larena SAS

Industry

Registry information

Official study 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

Acronym: MELIM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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