Status:
COMPLETED
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
Lead Sponsor:
Laboratoires Pronutri
Collaborating Sponsors:
Clin-Experts
Plateforme Cocolab
Conditions:
Stress
Eligibility:
All Genders
18+ years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05313867
Start Date
March 15 2022
End Date
June 10 2022
Last Update
February 21 2023
Active Locations (1)
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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