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

NCT05313867 | Completed

• 1 other identifier: 2021-A02571-40
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Stress; trace elements; voice parameters

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1 sequence of 10 tablets containing only excipients

Dietary Supplement: Placebo

Trace elements

EXPERIMENTAL

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

Interventions

Nutri VX 1 DIETARY_SUPPLEMENT

1 sequence of 10 tablets (one intake)

Trace elements

Placebo DIETARY_SUPPLEMENT

1 sequence of 10 tablets (one intake)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Pronutri: lead
• Clin-Experts: collaborator
• Plateforme Cocolab: collaborator

Study Sites (1)

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

Location

Study Officials

• Alice GUYON

  Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: April 6, 2022
• Study Start: March 15, 2022
• Primary Completion: June 10, 2022
• Study Completion: June 10, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)