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| Name | Class |
|---|---|
| CIC SANPSY (USR CNRS 3413), Groupe Hospitalier Pellegrin, Bordeaux, France | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botanical extract | Experimental |
| |
| Major compound of the extract | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botanical extract | Dietary Supplement | One capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol response to an acute stress | Area under the curve of the salivary cortisol concentration | Between baseline (before exposure to the stressor) and time 60 minutes after exposure to the stressor |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum salivary cortisol concentration | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SANPSY (CHU Pellegrin) | Bordeaux | 33076 | France |
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| Main compound of the botanical extract |
| Dietary Supplement |
one capsule |
|
| Placebo | Dietary Supplement | Maltodextrin, one capsule |
|
| Maximum change in heart rate variability parameters | 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 |
| Maximum increase in the anxiety score | 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 anxiety 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 |
| 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 |
| 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 |
| Percentage of correct answers in serial subtractions | During the subtractions tasks |
| Percentage of correct answers given during stress test | During the 60 minutes of the stress test |
| Mean number of total answers given per second. | During the 60 minutes of the stress test |