NCT06163794 Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People
| NCT ID | NCT06163794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement |
| Condition | Non Dependant 60 to 75 Year-old Men and Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-02-14 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-02-14 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * \- Subject with grip strength (assessed with a dynamometer) ≥16kg for women and ≥26 kg for men. * 21 ≤ BMI ≤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 Mini-Mental State Examination (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: * \- 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 corticosteroid 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 informed consent. * Subject under guardianship, curatorship, deprived of freedoms or under the protection of justice
Contact & Investigator
Gisèle Pichering, Pr
PRINCIPAL INVESTIGATOR
Centre d'Investigation Clinique
Frequently Asked Questions
Who can join the NCT06163794 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 75 Years, studying Non Dependant 60 to 75 Year-old Men and Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06163794 currently recruiting?
Yes, NCT06163794 is actively recruiting participants. Contact the research team at sergio.polakof@inrae.fr for enrollment information.
Where is the NCT06163794 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France, Clermont-Ferrand, France, Clermont-Ferrand, France.
Who is sponsoring the NCT06163794 clinical trial?
NCT06163794 is sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. The principal investigator is Gisèle Pichering, Pr at Centre d'Investigation Clinique. The trial plans to enroll 250 participants.