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

• Sponsor: Laboratoires Pronutri (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05313867
• Collaborator: Clin-Experts (Industry), Plateforme Cocolab (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.5
• Patients Per Site Per Month: 11.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress	Dietary Supplement: Nutri VX 1; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Mar 15, 2022
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 1 sequence of 10 tablets containing only excipients	Dietary Supplement: Placebo; 1 sequence of 10 tablets (one intake)
Experimental: 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.	Dietary Supplement: Nutri VX 1; 1 sequence of 10 tablets (one intake)

Outcome Measures

Primary Outcome Measures

1. F0 voice frequency [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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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		France	06100

Sponsors and Collaborators

• Laboratoires Pronutri
• Clin-Experts
• Plateforme Cocolab

Investigators

• Principal Investigator: Alice GUYON, Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratoires Pronutri
• ClinicalTrials.gov Identifier: NCT05313867
• Other Study ID Numbers: 2021-A02571-40
• First Posted: Apr 6, 2022
• Last Update Posted: Apr 6, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Laboratoires Pronutri: Stress; trace elements; voice parameters

Study Results

No Results Posted as of Apr 6, 2022