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Acute Effects of a Botanical Extract and Its Main Volatile Compound on Stress Response in Healthy Adults

NCT04523870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-11-22

No results posted yet for this study

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

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Botanical extract

One capsule

DIETARY_SUPPLEMENT

Main compound of the botanical extract

one capsule

DIETARY_SUPPLEMENT

Placebo

Maltodextrin, one capsule

Sponsors & Collaborators

  • CIC SANPSY (USR CNRS 3413), Groupe Hospitalier Pellegrin, Bordeaux, France

    collaborator UNKNOWN

  • Activ'inside

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2022-03-04
Completion
2022-03-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523870 on ClinicalTrials.gov