Status:
RECRUITING
Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People
Lead Sponsor:
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions:
Non Dependant 60 to 75 Year-old Men and Women
Eligibility:
All Genders
60-75 years
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 activi...
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 150 volunteers to establish "metabotypes" and have a better un...
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
February 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06163794
Start Date
February 14 2024
End Date
March 1 2026
Last Update
November 18 2024
Active Locations (3)
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1
Pic / Cic-Inserm 1405
Clermont-Ferrand, France, France, 63000
2
Plateforme d'Exploration de la Mobilité (CHU Clermont-Ferrand)
Clermont-Ferrand, France, 63009
3
Centre de Recherche en Odontologie Clinique, Faculté de Chirurgie Dentaire
Clermont-Ferrand, France, 63100