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 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 |
---|---|---|
|
N/A |
Study Design
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
- 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
Inclusion Criteria:
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Male or female over 18 years of age
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Healthy (healthy volunteers) (no current treatment except contraception and no acute illness within 3 months)
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Affiliated to the social security system
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Signed consent
Exclusion Criteria:
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Voice disorders: aphasia, dysphonia, aphonia...
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Presence of a cardiac pacemaker
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Person intolerant to lactose, or to any excipient present in the VX 1 product
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Person under legal protection or unable to give consent
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Minor
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Pregnant or post-pregnant woman under 6 months or of childbearing age without effective contraception
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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.- 2021-A02571-40