NCT05830565

Completed

Management of Occasional or Anticipatory Stress by Consumers...

Larena SAS Source

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Other study identifiers

Sponsor study identifier

PIL-RIPH3-MELIM-023

Study Type

observational

Actual enrollment (reported)

113

Locations

1 country

Sites

1

Timeline

Study Start

April 25, 2023

Actual (reported)

Primary Completion

June 22, 2023

Actual (reported)

Study Completion

June 25, 2023

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 113 participants
Study completion date: June 25, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 7, 2023
Actual (reported)
Study Start
April 25, 2023
Actual (reported)
First Posted
April 26, 2023
Actual (reported)
Primary Completion
June 22, 2023
Actual (reported)
Study Completion
June 25, 2023
Actual (reported)

Last Updated: November 13, 2023
Status Verified: May 2023
Last Update Submitted: November 10, 2023

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
+2 more secondary outcomes

Study Arms (1)

Food Supplement

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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)

Sponsors & Collaborators

Larena SAS
Industrylead

Study Sites (1)

Cen Experimental

Dijon, 21000, France

Study Officials

Carole Perrin
CEN
PRINCIPAL INVESTIGATOR

Enrollment

113 participants (actual enrollment reported by the registry).

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

Actual (reported)

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NCT05392621

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Not ApplicableCompleted

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)

Contact the study team to confirm eligibility.

Primary Completion

June 22, 2023

Actual (reported)

Study Completion

June 25, 2023

Actual (reported)

Last Updated

November 13, 2023

Record last verified: 2023-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05830565
Data provider: ClinicalTrials.gov
Source updated: 2023-11-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:03 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Food Supplement

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations