HealthyNCT04523870
Acute Effects of a Botanical Extract and Its Main Volatile Compound on Stress Response in Healthy Adults
A study testing Botanical extract and Main compound of the botanical extract in people with Healthy, run by Activ'inside at 1 site in France.
Trial summary
The prevalence of stress in daily human life increase in the investigator's modern life style. Short stress, could be benefit for memory, but prolonged stress may conduct to disturbance in cardiovascular, neuroendocrine and central nervous systems. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Botanical extract and Main compound of the botanical extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2020to 4 Mar 2022
- Phase
- Interventional
- 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 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker since at least 3 months
- Body Mass Index (BMI) in the normal range: 18.5 ≤ BMI < 25 kg/ m2 or "normal corpulence" according to investigator's judgment
- Usual waking hour between 6.00 and 9.00 am on weekdays
- Displaying a pattern of "reactive responder" to the stressor
- Subjects affiliated with a social security scheme
- Subjects capable of and willing to comply with the protocol and to give their written informed consent
Who cannot join
- Currently suffering from mental disorder or with personal history of such disease (depression, generalized anxiety disorder, obsessive compulsive disorder, panic disorder, simple phobia and social phobia, schizophrenia, …) according to the volunteer's self-declaration.
- Anxiolytic, antidepressant or any other treatment likely to affect some of the study parameters, whatever the reason of its prescription within the previous 3 months.
- Event (personal or professional) likely to have impacted the study parameters within 2 weeks before V1 (for example but not restricted to: change of professional function/ situation, death of a family member, divorce, surgery, accident, travel with jet lag …).
- Event (personal or professional) likely to affect the study parameters planned within the next 11 weeks, including but not restricted to: vaccination, travel with jet lag, …
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg during the V0 visit (Blood pressure will be measured while the subject sit in a chair. Blood pressure will be measured after a 10-minute rest and will be repeated 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated.)
- Subjects diagnosed with at least one of the following will not be eligible:
Show all 30Show fewer
- Present or recurrent infectious diseases (including cystitis, gingivitis, conjunctivitis, respiratory infections, …)
- Diabetes (type I or type II)
- Cardiovascular or vascular disease or history of cardiovascular or vascular disease (such as thrombosis, phlebitis, CVA, heart disease)
- Chronic disease affecting blood flow (examples: Raynaud's disease or syndrome, chronic veinous insuficiency)
- Allergic disease (asthma, allergic rhinitis, atopic dermatitis, …) or chronic inflammatory pathology (tendinitis, Crohn's disease, coeliac disease, …)
- Any other pathology which, according to investigator's judgment, is likely to affect the study parameters.
- Usual corticoïd treatment/ steroidal anti-inflammatory treatment (ex: Bétaméthasone, Cortivazol, Dexamethasone, Methylprednisolone, Prednisolone, Prednisone, Tétracosactide, Triamcinolone, …) including local treatments (ex : Locoïd lotion, Locatop, Locapred, Tridesonit, etc). Subjects will not be eligible if they have consumed such treatments within 2 weeks before V1 and/ or if they are likely to consume such treatments during the study;
- Oral antibiotic treatment within the last 2 weeks before entry into the study. In case of oral antibiotic started after inclusion, the next study visits of the participant will be reported until at least 2 weeks after the end of the antibiotic treatment.
- Unbalanced thyroid disease. However, subjects with controlled thyroid diseases (medication unchanged within the last 3 months) can be included;
- Suffering from a severe chronic pathology which, according to Investigator's judgment, is likely to affect at least one of the study parameters (such as but not restricted to: severe chronic pain, cancer or history of cancer unless in remission for more than 5 years, HIV, hepatitis, renal disease, cardiac disease);
- High physical activity practice: more than 10 hours per week of moderate to vigorous physical activity, or physical activity practice modified since less than 2 months or likely to be significantly modified within the next 11 weeks. Examples of moderate physical activity are: transporting light loads, bicycling at a normal pace, a double tennis, ... Walking is not considered as physical activity of moderate intensity.
- Subjects working in shift schedules (ex : nurse, baker, etc)
- Subjects whose working conditions are variable and likely to be extreme (ex: work in a cold room);
- Subjects consuming more than 3 coffee servings from waking until lunch (included), i.e. more than a bowl at breakfast + a cup in the morning + a cup at lunch.
- Subjects consuming any food supplement (including vitamins, minerals and botanicals and/or other substances) and refusing to stop for at least 2 weeks before V1 (inclusion visit) and until the end of his study participation;
- Usual alcohol consumption > 3 glasses/ day or chronic alcohol abuse treated since less than 3 months;
- Subjects with usual consumption of recreational drug. Subjects with occasional consumption of recreational drug can be include if they agree not to consume such products for at least one week before V1 and until the end of their study participation.
- Change in dietary habits since less than 4 weeks or planned within the next 11 weeks.
- Eating disorders: anorexia and bulimia or unstable dietary pattern.
- Any food allergy documented or suspected to one of the components of the study products.
- Subject presenting a psychological or linguistic inability to sign the informed consent.
- Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision.
- Subject having received indemnities for clinical trial reaching at least 4500 Euros considering the last 12 months.
- Subject participating in another biomedical study or during the exclusion period of a previous study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of a Botanical Extract and Its Main Volatile Compound on Stress Response in Healthy Adults: Randomized, Cross-over (Three Arms), Double-blind, Placebo-controlled Clinical Trial
The prevalence of stress in daily human life increase in the investigator's modern life style. Short stress, could be benefit for memory, but prolonged stress may conduct to disturbance in cardiovascular, neuroendocrine and central nervous systems. Moreover, it is well established that stress is the most common risk factor for the development of mood and anxiety disorders, such as major depressive disorder (MDD) and generalized anxiety disorder. In response to stress, hypothalamic-pituitary-adrenocortical (HPA) axis is one of activated pathway, which induce the cortisol release. Certain natural products could increase resilience to stress. Indeed, several preclinical studies have already showed that botanical extracts inhibited the typical plasmatic corticosterone elevation induced by an acute stress challenge. Therefore, the aim of this clinical trial is to investigate the acute effects of a botanical extract and one of his major compound, both delivered as sublingual single dose, on cortisol level, cardiac parameters, and psychometric response, in healthy adults exposed to an acute psychological stress.
- Conditions
- Healthy
- Being tested
- Botanical extract, Main compound of the botanical extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botanical extractDietary supplement
One capsule
Main compound of the botanical extractDietary supplement
one capsule
PlaceboDietary supplement
Maltodextrin, one capsule
| Study group | Role | What they receive |
|---|---|---|
| Botanical extract | Experimental | Not described Receives: Dietary Supplement: Botanical extract |
| Major compound of the extract | Experimental | Not described Receives: Dietary Supplement: Main compound of the botanical extract |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol response to an acute stress
Area under the curve of the salivary cortisol concentration
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Secondary outcomes (13)
Maximum salivary cortisol concentration
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Time of maximum of salivary cortisol concentration
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Maximum change in heart rate variability parameters
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Area under the curve of heart rate variability parameters
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Maximum increase in the anxiety score
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Time of maximum increase in the anxiety score
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Area under the curve of the anxiety score
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Maximum increase in the perceived stress score
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Time of maximum increase in the perceived stress score
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Area under the curve of the perceived stress score
Measured: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Percentage of correct answers in serial subtractions
Measured: During the subtractions tasks
Percentage of correct answers given during stress test
Measured: During the 60 minutes of the stress test
Mean number of total answers given per second.
Measured: During the 60 minutes of the stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start16 Sep 2020
- Primary completion4 Mar 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Activ'inside
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIC SANPSY (USR CNRS 3413), Groupe Hospitalier Pellegrin, Bordeaux, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523870
- Sponsor's protocol ID
- SAFRAI2018
- Status last verified
- Nov 2022
- First submitted
- 30 Jul 2020
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of a Botanical Extract and Its Main Volatile Compound on Stress Response in Healthy Adults: Randomized, Cross-over (Three Arms), Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04523870
- Acronym / sponsor ID
- SAFRAI2018
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Activ'insideIndustry (pharma, biotech, devices)
- Collaborators
- CIC SANPSY (USR CNRS 3413), Groupe Hospitalier Pellegrin, Bordeaux, France
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 24 Aug 2020 (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.
The prevalence of stress in daily human life increase in the investigator's modern life style. Short stress, could be benefit for memory, but prolonged stress may conduct to disturbance in cardiovascular, neuroendocrine and central nervous systems. Moreover, it is well established that stress is the most common risk factor for the development of mood and anxiety disorders, such as major depressive disorder (MDD) and generalized anxiety disorder. In response to stress, hypothalamic-pituitary-adrenocortical (HPA) axis is one of activated pathway, which induce the cortisol release. Certain natural products could increase resilience to stress. Indeed, several preclinical studies have already showed that botanical extracts inhibited the typical plasmatic corticosterone elevation induced by an acute stress challenge. Therefore, the aim of this clinical trial is to investigate the acute effects of a botanical extract and one of his major compound, both delivered as sublingual single dose, on cortisol level, cardiac parameters, and psychometric response, in healthy adults exposed to an acute psychological stress.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botanical extract | Experimental | Dietary Supplement: Botanical extract |
| Major compound of the extract | Experimental | Dietary Supplement: Main compound of the botanical extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoker since at least 3 months
- Body Mass Index (BMI) in the normal range: 18.5 ≤ BMI < 25 kg/ m2 or "normal corpulence" according to investigator's judgment
- Usual waking hour between 6.00 and 9.00 am on weekdays
- Displaying a pattern of "reactive responder" to the stressor
- Subjects affiliated with a social security scheme
Key exclusion criteria (30 listed)
- Currently suffering from mental disorder or with personal history of such disease (depression, generalized anxiety disorder, obsessive compulsive disorder, panic disorder, simple phobia and social phobia, schizophrenia, …) according to the volunteer's self-declaration.
- Anxiolytic, antidepressant or any other treatment likely to affect some of the study parameters, whatever the reason of its prescription within the previous 3 months.
- Event (personal or professional) likely to have impacted the study parameters within 2 weeks before V1 (for example but not restricted to: change of professional function/ situation, death of a family member, divorce, surgery, accident, travel with jet lag …).
- Event (personal or professional) likely to affect the study parameters planned within the next 11 weeks, including but not restricted to: vaccination, travel with jet lag, …
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg during the V0 visit (Blood pressure will be measured while the subject sit in a chair. Blood pressure will be measured after a 10-minute rest and will be repeated 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botanical extractOne capsule | Dietary supplement | Botanical extract |
| Main compound of the botanical extractone capsule | Dietary supplement | Major compound of the extract |
| PlaceboMaltodextrin, one capsule | Dietary supplement | Placebo |
Primary outcome
Cortisol response to an acute stress
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Area under the curve of the salivary cortisol concentration
13 secondary outcomes
Maximum salivary cortisol concentration
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Time of maximum of salivary cortisol concentration
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Maximum change in heart rate variability parameters
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Area under the curve of heart rate variability parameters
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Maximum increase in the anxiety score
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Time of maximum increase in the anxiety score
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Area under the curve of the anxiety score
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Maximum increase in the perceived stress score
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Time of maximum increase in the perceived stress score
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Area under the curve of the perceived stress score
Time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor
Percentage of correct answers in serial subtractions
Time frame: During the subtractions tasks
Percentage of correct answers given during stress test
Time frame: During the 60 minutes of the stress test
Mean number of total answers given per second.
Time frame: During the 60 minutes of the stress test
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 22 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botanical extract and Main compound of the botanical extract in people with Healthy, run by Activ'inside 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 6 inclusion and 30 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 22 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Cortisol response to an acute stress (time frame: Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor). 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 22 Nov 2022.