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

Activ'inside1 site in 1 country19 target enrollmentSeptember 16, 2020

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Activ'inside
Enrollment: 19
Locations: 1
Primary Endpoint: Cortisol response to an acute stress
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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. 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.

Registry

clinicaltrials.gov

Start Date

September 16, 2020

End Date

March 4, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Activ'inside

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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:
•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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

Area under the curve of the anxiety score(Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor)
Maximum increase in the anxiety score(Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor)
Mean number of total answers given per second.(During the 60 minutes of the stress test)
Maximum salivary cortisol concentration(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(Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor)
Time of maximum of salivary cortisol concentration(Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor)
Maximum change in heart rate variability parameters(Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor)
Time of maximum increase in the anxiety score(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(Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor)
Maximum increase in the perceived stress score(Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor)
Percentage of correct answers in serial subtractions(During the subtractions tasks)
Time of maximum increase in the perceived stress score(Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor)
Percentage of correct answers given during stress test(During the 60 minutes of the stress test)