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

NCT04523870 | Completed DMC

• 1 other identifier: SAFRAI2018
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• 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

• 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

Study Arms (3)

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

Interventions

Botanical extract DIETARY_SUPPLEMENT

One capsule

Botanical extract

Main compound of the botanical extract DIETARY_SUPPLEMENT

one capsule

Major compound of the extract

Placebo DIETARY_SUPPLEMENT

Maltodextrin, one capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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;
• 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);

Sponsors & Collaborators

• Activ'inside: lead
• CIC SANPSY (USR CNRS 3413), Groupe Hospitalier Pellegrin, Bordeaux, France: collaborator

Study Sites (1)

SANPSY (CHU Pellegrin)

Bordeaux, 33076, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 24, 2020
• Study Start: September 16, 2020
• Primary Completion: March 4, 2022
• Study Completion: March 4, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

FR (1)