Trials / Completed
CompletedNCT04523870
Acute Effects of a Botanical Extract and Its Main Volatile Compound on Stress Response in Healthy Adults
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Activ'inside · Industry
- Sex
- Male
- Age
- 18 Years – 25 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Botanical extract | One capsule |
| DIETARY_SUPPLEMENT | Main compound of the botanical extract | one capsule |
| DIETARY_SUPPLEMENT | Placebo | Maltodextrin, one capsule |
Timeline
- Start date
- 2020-09-16
- Primary completion
- 2022-03-04
- Completion
- 2022-03-04
- First posted
- 2020-08-24
- Last updated
- 2022-11-22
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04523870. Inclusion in this directory is not an endorsement.