StressNCT05313867
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
A study testing Nutri VX 1 in people with Stress, run by Laboratoires Pronutri at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Nutri VX 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2022to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
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
About this study
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
- Being tested
- Nutri VX 1, Placebo
- Keywords
- Stress, trace elements, voice parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutri VX 1Dietary supplement
1 sequence of 10 tablets (one intake)
PlaceboDietary supplement
1 sequence of 10 tablets (one intake)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 sequence of 10 tablets containing only excipients Receives: 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. Receives: Dietary Supplement: Nutri VX 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: Change from baseline at 5 minutes after the intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Mar 2022
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Pronutri
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clin-Experts, Plateforme Cocolab
- Responsible party
- Sponsor
- Investigators
- Alice GUYON, Principal investigator, Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313867
- Sponsor's protocol ID
- 2021-A02571-40
- Status last verified
- Feb 2023
- First submitted
- 20 Mar 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05313867
- Acronym / sponsor ID
- 2021-A02571-40
- Conditions
- Stress
- Keywords
- Stress, trace elements, voice parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Laboratoires PronutriIndustry (pharma, biotech, devices)
- Collaborators
- Clin-Experts, Plateforme Cocolab
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo1 sequence of 10 tablets containing only excipients |
| Trace elements | Experimental | Dietary Supplement: Nutri VX 1Nutri 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutri VX 11 sequence of 10 tablets (one intake) | Dietary supplement | Trace elements |
| Placebo1 sequence of 10 tablets (one intake) | Dietary supplement | Placebo |
Primary outcome
F0 voice frequency
Time frame: 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"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice GUYON principal investigator
Plateforme Cocolab - Maison des Sciences de l'Homme et de la Société Sud-Est
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutri VX 1 in people with Stress, run by Laboratoires Pronutri at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F0 voice frequency (time frame: Change from baseline at 5 minutes after the intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.