Stress
Conditions
Keywords
Stress, trace elements, voice parameters
Brief summary
Preliminary data obtained by the company Pronutri, which produces food supplements based on trace metals, suggests that food supplements containing trace metal compounds could act by reducing stress, which could result in effects on various physiological parameters. Trace elements are pure minerals essential to the functioning of our body, present in very small quantities. They have a precise and fundamental role in biological and information processes: a deficiency can lead to dysfunctions, often at the origin of our daily ailments. No scientific study has so far been carried out to measure the effects of these molecules on physiological and psychological parameters related to stress in healthy volunteers. The present study therefore aims to test the effects of these tablets containing metals and trace metals on the reduction of stress.
Interventions
DIETARY_SUPPLEMENTNutri VX 1
1 sequence of 10 tablets (one intake)
DIETARY_SUPPLEMENTPlacebo
1 sequence of 10 tablets (one intake)
Sponsors
Clin-Experts
Plateforme Cocolab
Laboratoires Pronutri
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female over 18 years of age * Healthy (healthy volunteers) (no current treatment except contraception and no acute illness within 3 months) * Affiliated to the social security system * Signed consent
Exclusion criteria
* Voice disorders: aphasia, dysphonia, aphonia... * Presence of a cardiac pacemaker * Person intolerant to lactose, or to any excipient present in the VX 1 product * Person under legal protection or unable to give consent * Minor * Pregnant or post-pregnant woman under 6 months or of childbearing age without effective contraception * Person deprived of liberty by a judicial or administrative decision or under psychiatric care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| F0 voice frequency | Change from baseline at 5 minutes after the intake | The vocal parameters will be evaluated using the Praat software (duration of sound in sec, average duration of pauses in sec, average vocal frequency expressed in Hz (F0), standard deviation of F0 expressed in Hz, minimum and maximum of F0, jitter and shimmer |
Countries
France
Outcome results
None listed