Correlations Between Nutrition and Urine Spot Checks Via a Urinary Self-test
NCT ID: NCT04621968
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
30 participants
OBSERVATIONAL
2020-12-31
2021-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre National de la Recherche Scientifique, France
OTHER
University Hospital, Toulouse
OTHER
Innopsys
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Innopsys-nurisens-2020
Identifier Type: -
Identifier Source: org_study_id