ClinicalTrials.gg
CompletedNCT06163794MetabotypAGEUpdated Nov 6, 2026

Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People

An interventional study of Nutritional postprandial test in Non Dependant 60 to 75 Year-old Men and Women, sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Completed at 3 sites in France. Open to participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Not applicable, Interventional, and Prevention

Updated Nov 6, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Not applicable
Ages
60 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 367 studies in Motor Activity with a site in France — 78 open to participants now, 90 under way, none of them phase 3. Motor Activity · France.

Enrollment
50th of 269
180 · median 62
Started
2024
with 21 others
No phase
254 of 367
52 open now
Registered
288th of 367
by date

Among the 367 studies in Motor Activity with a site in France, this one is the 50th largest by enrollment of the 269 interventional ones, is one of 22 that started in 2024, is one of 254 with no phase, and was the 288th registered.

By phase

367 studies; the count open now beside each. This study's row is marked.

No phasethis study254 · 52 open
Observational98 · 25 open
Phase 28 · 1 open
Phase 35 · 0 open
Phase 42 · 0 open

By the year they started

First in 1983; this study’s year is marked. 22 started in 2024.

Size and results

Median enrollment 62 across the 269 interventional studies, 98 across the 98 observational. Of the 230 that completed or were terminated, 3 (1%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 367 studies in Motor Activity with a site in France, or all of them as a file.
02

Study summary

There is high inter-individual variability in the response to feeding, which is determined by multiple interacting factors such as age, sex, genotype, gut microbiota, eating behaviors, physical activity or even socio-demographic factors. Original studies have recently demonstrated the possibility of predicting the postprandial response to the diet of healthy individuals on the basis of in-depth phenotyping, and of offering them foods adapted to their own metabolic capacities according to their belonging to different groups of individuals defined on the basis of the similarity of their metabolic capacities. Due to different life trajectories, inter-individual variability could be amplified upon entry into the aging period, which could explain at least in part why traditional strategies for managing chronic age-related pathologies are insufficient. The investigators aim is to propose a new strategy to better understand inter-individual variability in the response to food in the elderly based on deep phenotyping.

Read the detailed description

During a first phase of the project, the investigators defined all the parameters that could be measured to realize a deep phenotyping of volunteers to establish "metabotypes" and have a better understanding of the variability in the response to food. These parameters include: kinetics of change in postprandial blood glucose over a period of 4 hours following home consumption of four types of test meals (composite nutritional test); and measurement of several blood parameters either in the post-absorptive state, or in the post-prandial state, either after test meals at home, or after a fat meal in the research facility: triglycerides, insulin, C-Reactive-Protein, metabolites through open metabolomics, albumin, fatty acids, cytokines, different gene expression. Through questionnaires or tests the investigators will also assess:

food habits and preferences (with a special focus on polyphenols), olfactory and taste abilities, physical activity, muscle functionality, body composition, peripheral endothelial function and microvascular stiffness, blood pressure, oral status, cognitive function, stress and depression status, intestinal function, psycho-socio-economic status. Finally, the investigators will constitute a collection of blood, white cell, plasma, serum, saliva, urine and stool samples.

03

Conditions studied

  • Non Dependant 60 to 75 Year-old Men and Women

Browse trials for

Keywords

  • personalized nutrition
  • deep phenotyping
  • inter-individual variability
  • metabotypes
  • post-prandial response to food
  • metabolomics
  • physical activity and food intake behaviors
  • aging
  • citizen science
04

Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Subject with grip strength (assessed with a dynamometer) ≥16kg for women and ≥26 kg for men.
  • 21 ≤ ≤35
  • Participant living in a rural or peri-urban area or city dweller, according to the population density grid of the Territorial Observatory (categories 3, 2 or 1 respectively).
  • Cognitively able to perform tests and answer questionnaires according to the judgment of the recruiting doctor and on the basis of the (MMSE)
  • Available to carry out the entire protocol
  • Biological assessment considered by the investigator as compatible with participation in the study,
  • Subject agreeing to give written consent, and registration in the national file of volunteers who lend themselves to research
  • Person subject to a social security system.

Exclusion criteria

Exclusion Criteria:

  • - Diabetes treated
  • Sub-acute pathology (flu, gastroenteritis, bacterial infection, etc.) or trauma (fracture, surgical intervention, etc.) in the 30 days preceding inclusion.
  • Hepatocellular insufficiency,
  • Heart failure with decompensation,
  • Renal insufficiency (clearance \<30 ml/min)
  • Chronic anti-inflammatory treatment, long-term therapy > 1 month, infiltrations
  • Antibiotic treatment within 30 days prior to recruitment
  • Progressive pathology at the time of inclusion (cancer, etc.)
  • Gastrointestinal pathology deemed incompatible with the protocol
  • Eating habits incompatible with the protocol (allergies, test food intolerances/aversions, vegan diets, ketogenic diets, etc.)
  • Unstabilized thyroid diseases
  • Intense physical activity (activity causing shortness of breath and sweating) > 10 hours per week
  • Person who is in a period of exclusion on the National File of Healthy Volunteers
  • Subject presenting a psychiatric pathology or cognitive disorders making them incapable of giving .
  • Subject under guardianship, curatorship, deprived of freedoms or under the protection of justice
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    Non dependant 60 to 75 year-old men and women

    Deep phenotyping, including metabolic response to nutritional tests.

    Other: Nutritional postprandial test

Interventions

  • OtherNutritional postprandial test

    Metabolic responses to several test meals

06

What researchers measure

Primary outcomes

  1. Characterize the inter-individual variability of the blood glucose postprandial response

    Kinetics of change in postprandial blood glucose over a period of 4 hours following home consumption of four types of test meals by continuously monitoring blood glucose

    Time frame: Within the first month of study realization

Secondary outcomes

  1. Questionnaires about food habits and preferences (with a special focus on polyphenols)

    The investigators' objective is to have a good understanding of eating habits: estimation of precise food intake over three days but also long-term eating habits, preferences for sweet foods, salty foods, fatty foods. Participants will also be questioned about their general appetite, their neophobia, their culinary habits. An effort will be made to estimate polyphenol intake through specific questions.

    Time frame: Within the three months of study realization

  2. Test to assess taste abilities

    The participants will be offered drinks containing either water (n=2) or salted water (n=8), with various concentrations of salt. The objective is to determine which drinks contain salt or not. The score will vary from 0 (only bad answers) to 8 (only good answers). A score of 8 thus means that the taste abilities are good.

    Time frame: Within the first week of study realization

  3. Test to assess olfactory abilities

    Six groups of 4 vials will be presented to the participants. For each group of 4, only one vial has an odor. The first step will be to find the vial that does contain an odor. Then, the participant will have to identify the odor, choosing among 4 proposed odor. The score will increase with the number of vial found and the number of correct odor identification. It will thus vary from 0 to 8. If a participant has a score of 8, it means that he could detect each time in which vial there was an odor, and could each time identify the odor. Thus a score of 8 denotes very good olfactory abilities.

    Time frame: Within the first week of study realization

  4. Time to walk 4 meters

    The time to walk 4 m will be measured.

    Time frame: Within the first two months of study realization

  5. Time to stand up 5 times from a chair

    The time to stand up 5 times from a chair will be measured.

    Time frame: Within the first two months of study realization

  6. Maximum tolerated muscle power

    The maximum tolerated muscle power will be measured on a cycloergometer

    Time frame: Within the first two months of study realization

  7. Maximal isometric strength

    The maximal isometric strength of the quadriceps will be measured on an isometric measuring bench.

    Time frame: Within the first two months of study realization

  8. Questionnaires about usual physical activity

    The objective is to assess the amount of time usually spent by the participant for physical activity and for sedentary activities, the intensity of activities, through 28 questions. This questionnaire will give a categorical score, with 3 levels of physical activity: 1) Low: no physical activity or only low intensity activities. 2) Moderate: 3 or more days of intense activity lasting at least 20 min per day, or 5 days or more of moderate intensity activity and/or walking for at least 30 minutes per day, or 5 days or more of activity combining walking, moderate or high intensity activities. 3) Intense activity at least 3 days per week or 7 days or more of activity combining walking, moderate or high intensity activities

    Time frame: Within the first two months of study realization

  9. Measurement of total body lean mass (kg)

    Lean body mass will be measured by multi frequency electrical bio impedance (Bodystat QuadScan 4000). A weak electric current is delivered to the subject through electrodes, and the voltage is measured in order to calculate impedance (resistance and reactance) of the body. Most body water is stored in muscle. Therefore, if a person is more muscular there is a high chance that the person will also have more body water, which leads to lower impedance. Using the weight of the participant, through calibration curves, the system then calculates total body water, total body fat mass, and total body lean mass.

    Time frame: Within the first two months of study realization

  10. Measurement of total body fat mass (kg)

    Fat body mass will be measured by multi frequency electrical bio impedance (Bodystat QuadScan 4000). A weak electric current is delivered to the subject through electrodes, and the voltage is measured in order to calculate impedance (resistance and reactance) of the body. Most body water is stored in muscle. Therefore, if a person is more muscular there is a high chance that the person will also have more body water, which leads to lower impedance. Using the weight of the participant, through calibration curves, the system then calculates total body water, total body fat mass, and total body lean mass.

    Time frame: Within the first two months of study realization

  11. Measurement of peripheral endothelial function (RHI, %)

    Peripheral endothelial function of the participants will be assessed by tonometry using the Endo-PAT X system (Itamar Medical Ltd) before and after induction of post-occlusive reactive hyperemia. Endothelium-induced changes in vascular tone are measured at the fingertip using a pair of single-use plethysmographic sensors. The result obtained is the Reactive Hyperemia Index (RHI, %) which corresponds to the ratio between the amplitudes of the PAT® (Peripheral Arterial Tonometry) signal during hyperemia and the basal amplitudes of the occluded side, normalized by the values of the control arm. The values will be considered as normal if inferior to 1.67, and abnormal if higher than 1.67.

    Time frame: Within the first week of study realization

  12. Measurement of microvascular stiffness (Augmentation Index)

    Microvascular stiffness (=Augmentation Index) of the participants will be assessed by tonometry using the Endo-PAT X system (Itamar Medical Ltd). Augmentation Index (AI) will be calculated from the shape of the pulse wave recorded in basal conditions. This measurement is a recognized marker of cardiovascular risk. The AI value is inversely proportional to the stiffness of the vessels. The scale of the measurement is the following: Values between 20-80: healthy degree of arterial flexibility. Values between 81-100 : increased cardiovascular risk Values over 100: high cardiovascular risk.

    Time frame: Within the first week of study realization

  13. Assessment of oral status

    Oral status will be assessed through the Nordic Orofacial Test - Screening (NOT-S), which is a screening and evaluation tool for orofacial motor dysfunctions and disorders. It includes two parts: 1) "Maintenance" part containing 6 sections: sensory function, breathing, habits, chewing and swallowing, drooling, and dry mouth (I-VI); 2) "Examination" part comprising 6 sections: face at rest, nasal breathing, facial expression, function of the masticatory muscles and jaws, oral motor functions, and articulation of speech. The NOT-S total score ranges from 0 (no dysfunction) to 12 (high dysfunction). For each section, from the moment the subject answers "Yes" to one of the questions, the box is checked and results in a score of 1 in the last right column of the questionnaire.

    Time frame: Within the first two months of study realization.

  14. Assessment of cognitive function

    The cognitive abilities of the participants will be assessed using the CANTAB®, using a computer under supervision. This method makes it possible to assess 1) episodic memory; 2) verbal recognition memory, that is, immediate and delayed memory for verbal information; 3) Spatial working memory, which requires the retention and manipulation of visuospatial information. 4) The spatial span task (CANTAB spatial spam), which evaluates the maximum amount of information that the subject is capable of recalling after a single presentation.

    Time frame: Within the first week of study realization

  15. Assessment of depression status

    Participants' depressive nature will be assessed using the Geriatric Depression Scale (GDS) test. It is a self-questionnaire which contains 15 items, each with a binary Yes-No response. It is a commonly used tool to assess the presence of depressive symptoms in older adults. A score of 0 to 5 is considered normal. A score between 5 and 9 indicates a high likelihood of depression, and a score between 10 and 15 almost always indicates depression.

    Time frame: Within the first week of study realization.

  16. Assessment of socio-economic status

    The socio-economic status of participants will be assessed using the EPICES scale (Évaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé) which was developed in France by the National Institute of Prevention and Education for Health . This scale is used in public health to assess the social precariousness of individuals, which takes into account the multidimensional nature of precariousness. The main interest of the EPICES score consists of understanding populations which, while escaping the traditional administrative indicators of precariousness, present the same health risks. The EPICES score is based on 11 questions which summarize 90% of a subject's precarious situation. The answer to each question is assigned a coefficient, the sum of the 11 answers gives the EPICES score. The score is continuous, it varies from 0 (absence of precariousness) to 100 (maximum of precariousness).

    Time frame: Within the three months of study realization

  17. Assessment of self-esteem

    Participants' self-esteem will be assessed using the Rosenberg Self-Esteem Scale. It is a psychometric tool widely used in psychology research, social sciences and clinical settings. It consists of 10 questions to which respondents are asked to indicate their degree of agreement or disagreement using a 4-point Likert scale, ranging from "strongly disagree" to "strongly agree". The questions are designed to assess overall self-perception and personal esteem. The score between 10 and 40 which are interpreted according to specific thresholds.Higher scores indicate higher self-esteem.

    Time frame: Within the three months of study realization

  18. Assessment of intestinal function

    To have a better understanding of the characteristics of the participants' intestinal function, they will have to complete an intestinal transit diary. Such a diary is a tool used to record a person's stool habits and characteristics over a period of time. It is often used in the field of gastroenterology and nutrition to assess the functioning of the digestive system. Participants will note every day for 15 days: the frequency of stools, noting each time the time they had a bowel movement, as well as the consistency of stools based on the Bristol visual scale. which categorizes 7 types of stools, ranging from the hardest to the softest. Experts consider types 1 and 2 to be uncharacteristically hard and indicative of constipation, while types 6 and 7 are unusually loose and may indicate diarrhea. Medical professionals generally consider types 3, 4, and 5 to be the most typical. Overall, a qualitative assessment of intestinal function will be made, with no calculated score.

    Time frame: Within the first month of study realization

  19. Stool collection

    One sample of stool will be taken and analyzed by metagenomic.

    Time frame: Within the first month of study realization

  20. Measurement of plasma insulin levels (micro U / mL)

    These measurements will be made 1) in the post-absorptive state, 2) after the ingestion of 4 standards test meals, 3) after the ingestion of a sweet and fatty meal.

    Time frame: Within the first two months of study realization

  21. Measurement of plasma triglycerides levels (mg / dL)

    These measurements will be made 1) in the post-absorptive state, 2) after the ingestion of 4 standards test meals, 3) after the ingestion of a sweet and fatty meal.

    Time frame: Within the first two months of study realization

  22. Measurement of plasma C Reactive Protein (mg / L)

    These measurements will be made in the post-absorptive state.

    Time frame: Within the first two months of study realization

  23. Measurement of plasma amino acid levels (µMol)

    These measurements will be made 1) in the post-absorptive state 2) after the ingestion of a protein rich test meal.

    Time frame: Within the first two months of study realization

  24. Measurement of plasma metabolite through open metabolomics

    These measurements will be made 1) in the post-absorptive state 2) after the ingestion of a sweet and fatty meal.

    Time frame: Within the first two months of study realization

  25. Measurement of plasma free fatty acids (mg / L)

    These measurements will be made 1) in the post-absorptive state 2) after the ingestion of a sweet and fatty meal.

    Time frame: Within the first two months of study realization

  26. Measurement of plasma cytokines (U / L)

    These measurements will be made 1) in the post-absorptive state 2) after the ingestion of a sweet and fatty meal.

    Time frame: Within the first two months of study realization

  27. Measurement of plasma albumin (g / L)

    These measurements will be made in the post-absorptive state

    Time frame: Within the first two months of study realization

  28. Measurement of various gene expression in peripheral blood mononuclear cells isolated from blood samples.

    These measurements will be made in the post-absorptive state

    Time frame: Within the first two months of study realization

  29. Measurement of plasma oxylipins (nmol / L)

    These measurements will be made 1) in the post-absorptive state 2) after the ingestion of a sweet and fatty meal.

    Time frame: Within the first two months of study realization.

  30. Measurement of immune responsiveness (whole blood oxylipin and cytokine responses to immune stimulation).

    These measurements will be made in the post-absorptive state.

    Time frame: Within the first two months of study realization.

07

Study locations

3 sites
  • Pic / Cic-Inserm 1405
    Clermont-Ferrand, France 63000, France
  • Plateforme d'Exploration de la Mobilité (CHU Clermont-Ferrand)
    Clermont-Ferrand, 63009, France
  • Centre de Recherche en Odontologie Clinique, Faculté de Chirurgie Dentaire
    Clermont-Ferrand, 63100, France
08

References and documents

Publications

  • Ordovas JM, Ferguson LR, Tai ES, Mathers JC. Personalised nutrition and health. BMJ. 2018 Jun 13;361:bmj.k2173. doi: 10.1136/bmj.k2173. PubMed 29898881 ↗
  • Delude CM. Deep phenotyping: The details of disease. Nature. 2015 Nov 5;527(7576):S14-5. doi: 10.1038/527S14a. No abstract available. PubMed 26536218 ↗
  • de Toro-Martin J, Arsenault BJ, Despres JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8):913. doi: 10.3390/nu9080913. PubMed 28829397 ↗
  • Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11. PubMed 32528151 ↗
  • Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001. PubMed 26590418 ↗
  • Hillesheim E, Ryan MF, Gibney E, Roche HM, Brennan L. Optimisation of a metabotype approach to deliver targeted dietary advice. Nutr Metab (Lond). 2020 Sep 29;17:82. doi: 10.1186/s12986-020-00499-z. eCollection 2020. PubMed 33005208 ↗

Individual participant data

Plan to share: Yes — Sharing of all IPD that underlie results in a publication

Supporting information: Study protocol, Statistical analysis plan

Time frame: Beginning 6 months after publication, and for as long as necessary after that

Access criteria: The data will be shared with any researcher who requests it by email following publication.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2024 to primary completion in Oct 2026, 32 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 32 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 6, 2026: primary completion Jun 2026 → Oct 2026 and completion Mar 2027 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 10, 2023
First posted
Dec 11, 2023
StartActual
Feb 14, 2024
Primary completionActual
Oct 30, 2026was Jun 2026
CompletionActual
Oct 30, 2026was Mar 2027
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 6, 2026
Primary completion
Jun 30, 2026→Oct 30, 2026 (actual)
Nov 6, 2026
Study completion
Mar 2027→Oct 30, 2026 (actual)
Nov 6, 2026
Enrollment
250 (estimated)→180 (actual)
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Recruiting→Completed
    Primary completion Jun 30, 2026→Oct 30, 2026 (now actual)
    Study completion Mar 2027→Oct 30, 2026 (now actual)
    Enrollment 250 (estimated)→180 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06163794
Lead sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Responsible party
Sponsor
First posted
Dec 11, 2023
Start date
Feb 14, 2024
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026
Last update
Nov 6, 2026

Study contacts

Gisèle Pichering, Pr
principal investigator · Centre d'Investigation Clinique

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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