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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313867
• Other study ID #: 2021-A02571-40
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: June 10, 2022

Study information

• Verified date: February 2023
• Source: Laboratoires Pronutri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Dietary Supplement:
• Nutri VX 1
1 sequence of 10 tablets (one intake)
• Placebo
1 sequence of 10 tablets (one intake)

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
Laboratoires Pronutri	Clin-Experts, Plateforme Cocolab

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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