Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People

NCT ID: NCT06163794

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2026-03-31

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.

Conditions

Non Dependant 60 to 75 Year-old Men and Women

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

Nutritional postprandial test

Metabolic responses to several test meals

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle Pichering, Pr

Role: PRINCIPAL_INVESTIGATOR

Centre d'Investigation Clinique

Locations

Pic / Cic-Inserm 1405

Clermont-Ferrand, France, France

Site Status: RECRUITING

Plateforme d'Exploration de la Mobilité (CHU Clermont-Ferrand)

Clermont-Ferrand, , France

Site Status: NOT_YET_RECRUITING

Centre de Recherche en Odontologie Clinique, Faculté de Chirurgie Dentaire

Clermont-Ferrand, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Sergio Polakof, Ph D

Role: CONTACT

sergio.polakof@inrae.fr

+33473624895

Claudine Manach, Ph D

Role: CONTACT

claudine.manach@inrae.fr

+33473624826

Facility Contacts

Gisèle Pickering, Pr

Role: primary

gisele.pickering@uca.fr

+33473178416

Frédéric Costes, PhD MD

Role: primary

Noémie Drancourt, PhD MD

Role: primary

References

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Reference Type: BACKGROUND

PMID: 29898881 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 26590418 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33005208 (View on PubMed)

Delude CM. Deep phenotyping: The details of disease. Nature. 2015 Nov 5;527(7576):S14-5. doi: 10.1038/527S14a. No abstract available.

Reference Type: BACKGROUND

PMID: 26536218 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28829397 (View on PubMed)

Other Identifiers

INRAE-UNH-2023-1

Identifier Type: -

Identifier Source: org_study_id