Clinical trial NCT06163794: Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People
Official title: New Participatory Research Strategy and Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Dependant 60 to 75 Year-old Men and Women
Keywords: personalized nutrition
deep phenotyping
inter-individual variability
metabotypes
post-prandial response to food
metabolomics
physical activity and food intake behaviors
aging
citizen science
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women aged 60 to 75 years living in a rural or peri-urban area or city dweller.

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.

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 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.

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

Primary outcomes:
measure: Characterize the inter-individual variability of the blood glucose postprandial response
timeFrame: Within the first month of study realization
Secondary outcomes:
measure: Questionnaires about food habits and preferences (with a special focus on polyphenols)
timeFrame: Within the three months of study realization
measure: Test to assess taste abilities
timeFrame: Within the first week of study realization
measure: Test to assess olfactory abilities
timeFrame: Within the first week of study realization
measure: Time to walk 4 meters
timeFrame: Within the first two months of study realization
measure: Time to stand up 5 times from a chair
timeFrame: Within the first two months of study realization
measure: Maximum tolerated muscle power
timeFrame: Within the first two months of study realization
measure: Maximal isometric strength
timeFrame: Within the first two months of study realization
measure: Questionnaires about usual physical activity
timeFrame: Within the first two months of study realization
measure: Measurement of total body lean mass (kg)
timeFrame: Within the first two months of study realization
measure: Measurement of total body fat mass (kg)
timeFrame: Within the first two months of study realization
measure: Measurement of peripheral endothelial function (RHI, %)
timeFrame: Within the first week of study realization
measure: Measurement of microvascular stiffness (Augmentation Index)
timeFrame: Within the first week of study realization
measure: Assessment of oral status
timeFrame: Within the first two months of study realization.
measure: Assessment of cognitive function
timeFrame: Within the first week of study realization
measure: Assessment of depression status
timeFrame: Within the first week of study realization.
measure: Assessment of socio-economic status
timeFrame: Within the three months of study realization
measure: Assessment of self-esteem
timeFrame: Within the three months of study realization
measure: Assessment of intestinal function
timeFrame: Within the first month of study realization
measure: Stool collection
timeFrame: Within the first month of study realization
measure: Measurement of plasma insulin levels (micro U / mL)
timeFrame: Within the first two months of study realization
measure: Measurement of plasma triglycerides levels (mg / dL)
timeFrame: Within the first two months of study realization
measure: Measurement of plasma C Reactive Protein (mg / L)
timeFrame: Within the first two months of study realization
measure: Measurement of plasma amino acid levels (µMol)
timeFrame: Within the first two months of study realization
measure: Measurement of plasma metabolite through open metabolomics
timeFrame: Within the first two months of study realization
measure: Measurement of plasma free fatty acids (mg / L)
timeFrame: Within the first two months of study realization
measure: Measurement of plasma cytokines (U / L)
timeFrame: Within the first two months of study realization
measure: Measurement of plasma albumin (g / L)
timeFrame: Within the first two months of study realization
measure: Measurement of various gene expression in peripheral blood mononuclear cells isolated from blood samples.
timeFrame: Within the first two months of study realization
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Pic / Cic-Inserm 1405
city: Clermont-Ferrand
country: France
facility: Plateforme d'Exploration de la Mobilité (CHU Clermont-Ferrand)
city: Clermont-Ferrand
country: France
facility: Centre de Recherche en Odontologie Clinique, Faculté de Chirurgie Dentaire
Study officials:
affiliation: Centre d'Investigation Clinique
name: Gisèle Pichering, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ordovas JM, Ferguson LR, Tai ES, Mathers JC. Personalised nutrition and health. BMJ. 2018 Jun 13;361:bmj.k2173. doi: 10.1136/bmj.k2173.
citation: 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.
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citation: 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.
citation: Delude CM. Deep phenotyping: The details of disease. Nature. 2015 Nov 5;527(7576):S14-5. doi: 10.1038/527S14a. No abstract available.
citation: 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.