Diet, HealthyNCT04621968
Correlations Between Nutrition and Urine Spot Checks Via a Urinary Self-test
An observational study of Diet, Healthy, run by Innopsys.
Trial summary
An inclusion consultation carried out by Professor Gamé at the CHU of Toulouse (Rangueil site) will make it possible to provide the subject with a urinary self-test which automatically carries out and sends the measurement of 10 urinary parameters: pH, density, creatinine, magnesium, calcium, sodium, urea, uric aid… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Oct 2021
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers with sport
Who may be able to join
- -
Who cannot join
- chronic disease
Trial locations and contacts
No sites are listed yet.
About this study
An inclusion consultation carried out by Professor Gamé at the CHU of Toulouse (Rangueil site) will make it possible to provide the subject with a urinary self-test which automatically carries out and sends the measurement of 10 urinary parameters: pH, density, creatinine, magnesium, calcium, sodium, urea, uric aid, oxalate, citrate.
No samples are taken and therefore stored.
The data will be processed by IRIT in order to investigate :
- the correlation of the analyses with the context of nutrition and sports activity.
- the best recommendation on use (the best time)
Translated with www.DeepL.com/Translator (free version)
Read the detailed description
Hypothesis We assume that frequent occasional urinary analyses carried out independently by the subject allow us to identify changes in diet.
Final objective:
We would like to determine:
- a strong correlation between the different markers and the nutritional context
- the impact of physical activity on this correlation
- the most relevant moment of analysis (optimising correlation) in order to define recommendations for use
Protocol:
During the inclusion consultation, Professor Gamé will provide the subject's self-test, mobile application and user account. The correspondence table between the user account and the data identifying the subject will only be accessible and kept by Professor Gamé and his team. During this consultation, will be exposed :
- the context and objectives of the study
- the use of the self-test and its recommendations
Thus, no samples will be taken and therefore retained. The cartridges are single-use cartridges and will therefore be thrown away by the subject. The reader will be returned to the partner who developed it (Innopsys) at the end of the protocol.
The subject will have recommendations on the frequency of use which will not be binding and will not have any impact on his participation in the trial. These recommendations will be composed of 2 phases:
Phase 1: frequency of use: 3X/day for 1 month. Phase 2: Frequency of free use. This phase will make it possible to observe the level of acceptability of the technology.
The subject will provide information on his diet by sending a photo of his meals via the mobile application provided. This will then be analysed by algorithms (or operators if the accuracy of the algorithms is insufficient) to extract the type and quantity of food ingested.
Throughout the protocol, the subject will be able to send summary data of his or her sporting activities via the web application linked to the project. These data will be :
- The number of steps taken
- Average heart rate
- The duration of the effort
- The theoretical energy expended
The subject may request a consultation with Professor Gamé during the study in order to have a medical opinion on these results.
- Conditions
- Diet, Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation graph between nutrition and urinary measurements
Measured: decembre 2020- May 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innopsys
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre National de la Recherche Scientifique, France, University Hospital, Toulouse
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621968
- Sponsor's protocol ID
- Innopsys-nurisens-2020
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Nutrition and Urine Spot Checks Via a Urinary Self-test
- ClinicalTrials.gov ID
- NCT04621968
- Acronym / sponsor ID
- Innopsys-nurisens-2020
- Conditions
- Diet, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- InnopsysIndustry (pharma, biotech, devices)
- Collaborators
- Centre National de la Recherche Scientifique, France, University Hospital, Toulouse
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 9 Nov 2020 (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.
An inclusion consultation carried out by Professor Gamé at the CHU of Toulouse (Rangueil site) will make it possible to provide the subject with a urinary self-test which automatically carries out and sends the measurement of 10 urinary parameters: pH, density, creatinine, magnesium, calcium, sodium, urea, uric aid, oxalate, citrate.
No samples are taken and therefore stored.
The data will be processed by IRIT in order to investigate :
- the correlation of the analyses with the context of nutrition and sports activity.
- the best recommendation on use (the best time)
Translated with www.DeepL.com/Translator (free version)
Detailed description
Hypothesis We assume that frequent occasional urinary analyses carried out independently by the subject allow us to identify changes in diet.
Final objective:
We would like to determine:
- a strong correlation between the different markers and the nutritional context
- the impact of physical activity on this correlation
- the most relevant moment of analysis (optimising correlation) in order to define recommendations for use
Protocol:
During the inclusion consultation, Professor Gamé will provide the subject's self-test, mobile application and user account. The correspondence table between the user account and the data identifying the subject will only be accessible and kept by Professor Gamé and his team. During this consultation, will be exposed :
- the context and objectives of the study
- the use of the self-test and its recommendations
Thus, no samples will be taken and therefore retained. The cartridges are single-use cartridges and will therefore be thrown away by the subject. The reader will be returned to the partner who developed it (Innopsys) at the end of the protocol.
The subject will have recommendations on the frequency of use which will not be binding and will not have any impact on his participation in the trial. These recommendations will be composed of 2 phases:
Phase 1: frequency of use: 3X/day for 1 month. Phase 2: Frequency of free use. This phase will make it possible to observe the level of acceptability of the technology.
The subject will provide information on his diet by sending a photo of his meals via the mobile application provided. This will then be analysed by algorithms (or operators if the accuracy of the algorithms is insufficient) to extract the type and quantity of food ingested.
Throughout the protocol, the subject will be able to send summary data of his or her sporting activities via the web application linked to the project. These data will be :
- The number of steps taken
- Average heart rate
- The duration of the effort
- The theoretical energy expended
The subject may request a consultation with Professor Gamé during the study in order to have a medical opinion on these results.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers with sport
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation graph between nutrition and urinary measurements
Time frame: decembre 2020- May 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet, Healthy, run by Innopsys.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Le Brun (+33561971976, s-lebrun@innopsys.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation graph between nutrition and urinary measurements (time frame: decembre 2020- May 2021). 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 9 Nov 2020.