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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2022-06-10

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.

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Detailed Description

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Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

1 sequence of 10 tablets containing only excipients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1 sequence of 10 tablets (one intake)

Trace elements

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.

Group Type EXPERIMENTAL

Nutri VX 1

Intervention Type DIETARY_SUPPLEMENT

1 sequence of 10 tablets (one intake)

Interventions

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Nutri VX 1

1 sequence of 10 tablets (one intake)

Intervention Type DIETARY_SUPPLEMENT

Placebo

1 sequence of 10 tablets (one intake)

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes