StressMELIMNCT05830565
Management of Occasional or Anticipatory Stress by Consumers of a Food Supplement
An observational study of Stress, run by Larena SAS at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2023to 25 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult believing that they could be exposed to a stressful event in the next 2 months
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Food Supplement | Single dose of food Supplement Based on L-theanine, Passionflower and Rhodiola Extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and 20 minutes after product intake
Secondary outcomes (7)
Percentage of stress enhancement responders
Percentage of volunteers with a decrease in the VAS scale
Measured: 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
Measured: 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
Percentage of volunteers with a decrease in the stress-related signs VAS scales
Measured: Before and 20 minutes after product intake
Percentage of stress-related signs enhancement responders
Percentage of volunteers with a decrease in the stress-related signs VAS scales
Measured: Before and 20 minutes after product intake
EvaluatIon of the organoleptic properties
Evaluation with a Likert scale, minimum = very unpleasant and maximum = pleasant higher score means a best outcome
Measured: Before midnight
satisfaction felt by volunteers
Evaluation with a Likert scale, minimum = not effective and maximum = very effective higher score means a best outcome
Measured: Before midnight
Adverse events
Number and type of adverse events
Measured: Before midnight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start25 Apr 2023
- Primary completion22 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larena SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carole Perrin, Principal investigator, CEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830565
- Sponsor's protocol ID
- PIL-RIPH3-MELIM-023
- Acronym
- MELIM
- Status last verified
- May 2023
- First submitted
- 7 Mar 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05830565
- Acronym / sponsor ID
- MELIM / PIL-RIPH3-MELIM-023
- Conditions
- Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Larena SASIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food Supplement | – | –Single dose of food Supplement Based on L-theanine, Passionflower and Rhodiola Extracts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult believing that they could be exposed to a stressful event in the next 2 months
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Percentage of stress enhancement responders
Time frame: Before and 20 minutes after product intake
Evolution of level of felt stress
Time frame: 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
Time frame: Before and 20 minutes after product intake
Percentage of stress-related signs enhancement responders
Time frame: Before and 20 minutes after product intake
EvaluatIon of the organoleptic properties
Time frame: Before midnight
satisfaction felt by volunteers
Time frame: Before midnight
Adverse events
Time frame: Before midnight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Perrin principal investigator
CEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by Larena SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of level of felt stress before and after product intake (time frame: Before and 20 minutes after product intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.