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

Stress Clinical Trial

— MELIM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05830565
• Other study ID #: PIL-RIPH3-MELIM-023
• Status: Completed
• Start date: April 25, 2023
• Est. completion date: June 25, 2023

Study information

• Verified date: May 2023
• Source: Larena SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 25, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stress

Locations

Country	Name	City	State
France	Cen Experimental	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Larena SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of stress enhancement responders	Percentage of volunteers with a decrease in the VAS scale	Before and 20 minutes after product intake
Secondary	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
Secondary	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
Secondary	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
Secondary	EvaluatIon of the organoleptic properties	Evaluation with a Likert scale, minimum = very unpleasant and maximum = pleasant higher score means a best outcome	Before midnight
Secondary	satisfaction felt by volunteers	Evaluation with a Likert scale, minimum = not effective and maximum = very effective higher score means a best outcome	Before midnight
Secondary	Adverse events	Number and type of adverse events	Before midnight