- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621968
Correlations Between Nutrition and Urine Spot Checks Via a Urinary Self-test
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)
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stéphane Le Brun
- Phone Number: +33561971976
- Email: s-lebrun@innopsys.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-
Exclusion Criteria:
chronic disease
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation graph between nutrition and urinary measurements
Time Frame: decembre 2020- May 2021
|
decembre 2020- May 2021
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Innopsys-nurisens-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diet, Healthy
-
University of ReadingActive, not recruitingDiet Modification | Diet, Healthy | Diet HabitUnited Kingdom
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
Washington State UniversityUnited States Department of Agriculture (USDA)Not yet recruitingHealth Behavior | Diet, Healthy | Diet HabitUnited States
-
Lund UniversityCompletedHealthy Subjects | Diet, HealthySweden
-
Luis María Béjar PradoRecruitingHealthy Eating Index | Mediterranean Diet | Diet HabitsSpain
-
University of MinnesotaRecruiting
-
Swiss Federal Institute of TechnologyCompletedHealthy Aging | Healthy DietSwitzerland
-
University of HawaiiPennington Biomedical Research Center; United States Department of Agriculture...RecruitingDiet, HealthyUnited States
-
Harokopio UniversityRecruiting
-
Universitas Katolik Widya Mandala SurabayaNot yet recruitingDiet, HealthyIndonesia