Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Dietary Supplements Based on Trace Elements on Voice Parameters and Some Psychological and Physiological Parameters Related to Stress - Single-center, Comparative, Cross-over, Randomized, Double-blind Study Versus Placebo, in Healthy Subjects

Conditions
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Stress

Intervention / Treatment
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* Dietary Supplement: Nutri VX 1
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>1 sequence of 10 tablets containing only excipients | Dietary Supplement: Placebo<br>* 1 sequence of 10 tablets (one intake)<br>|
| Experimental: Trace elements<br>Nutri VX1 in a single dose (1 sequence of 10 tablets). Nutri VX1 is a complex of trace elements with the status of a food supplement. | Dietary Supplement: Nutri VX 1<br>* 1 sequence of 10 tablets (one intake)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| F0 voice frequency | 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 | Change from baseline at 5 minutes after the intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, trace elements, voice parameters