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

Laboratoires Pronutri

Status: Completed

Conditions: Stress

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Nutri VX 1

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05313867

2021-A02571-40

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1 sequence of 10 tablets containing only excipients

Treatment:

Dietary Supplement: Placebo

Trace elements

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nutri VX 1