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

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.

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Key information

Conditions

Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est, 24, avenue des Diables Bleus, Campus Saint Jean d'Angély

Nice, 06100, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutri VX 1

Dietary Supplement

1 sequence of 10 tablets (one intake)

Placebo

Dietary Supplement

1 sequence of 10 tablets (one intake)

Primary outcomes

F0 voice frequency

Time frame: 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"

Sponsors and collaborators

Lead sponsor

Laboratoires Pronutri

Industry

Collaborators

Clin-Experts
Plateforme Cocolab

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 6, 2022
Registry last updated: Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed