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

NCT05830565 | Completed

• 1 other identifier: PIL-RIPH3-MELIM-023
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percentage of stress enhancement responders

  Before and 20 minutes after product intake

• Evolution of level of felt stress

  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

  Before and 20 minutes after product intake

• Percentage of stress-related signs enhancement responders

  Before and 20 minutes after product intake

• EvaluatIon of the organoleptic properties

  Before midnight

Study Arms (1)

Food Supplement

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult believing that they could be exposed to a stressful event in the next 2 months

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Larena SAS: lead

Study Sites (1)

Cen Experimental

Dijon, 21000, France

Location

Study Officials

• Carole Perrin

  CEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 26, 2023
• Study Start: April 25, 2023
• Primary Completion: June 22, 2023
• Study Completion: June 25, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-05

Locations

FR (1)