Management of Occasional or Anticipatory Stress by Consum... | NCT05830565

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

NCT05830565

Sponsor

Larena SAS

Status

Completed

Last Update Posted

Nov 13, 2023Actual

Enrollment

113Actual

Phase

Not provided

Conditions

Stress

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2023Actual

Primary Completion Date

Jun 22, 2023Actual

Completion Date

Jun 25, 2023Actual

First Submitted Date

Mar 7, 2023

First Submission Date that Met QC Criteria

Apr 24, 2023

First Posted Date

Apr 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2023

Last Update Posted Date

Nov 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

113Actual

Label	Type	Description	Intervention Names
Food Supplement		Single dose of food Supplement Based on L-theanine, Passionflower and Rhodiola Extracts

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Percentage of stress enhancement responders	Percentage of volunteers with a decrease in the VAS scale	Before and 20 minutes after product intake
Evolution of level of felt stress	Change in stress VAS (visual analogue scale), minimum = 0 and maximum = 10 higher score means a worse outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample