Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People

NCT06163794 | Recruiting DMC

• 1 other identifier: INRAE-UNH-2023-1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

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

  Within the first month of study realization

Secondary Outcomes (30)

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

  Within the three months of study realization

• Test to assess taste abilities

  Within the first week of study realization

• Test to assess olfactory abilities

  Within the first week of study realization

• Time to walk 4 meters

  Within the first two months of study realization

• Time to stand up 5 times from a chair

  Within the first two months of study realization

Study Arms (1)

Non dependant 60 to 75 year-old men and women

EXPERIMENTAL

Deep phenotyping, including metabolic response to nutritional tests.

Other: Nutritional postprandial test

Interventions

Nutritional postprandial test OTHER

Metabolic responses to several test meals

Non dependant 60 to 75 year-old men and women

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subject with grip strength (assessed with a dynamometer) ≥16kg for women and ≥26 kg for men.
• ≤ 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.

You may not qualify if:

• \- Diabetes treated
• 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
• 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
• 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

Sponsors & Collaborators

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

Study Sites (3)

Pic / Cic-Inserm 1405

Clermont-Ferrand, France, 63000, France

RECRUITING

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

Clermont-Ferrand, 63009, France

RECRUITING

Centre de Recherche en Odontologie Clinique, Faculté de Chirurgie Dentaire

Clermont-Ferrand, 63100, France

RECRUITING

Related Publications (6)

• Ordovas JM, Ferguson LR, Tai ES, Mathers JC. Personalised nutrition and health. BMJ. 2018 Jun 13;361:bmj.k2173. doi: 10.1136/bmj.k2173.

  PMID: 29898881 BACKGROUND

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

  PMID: 26536218 BACKGROUND

• 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.

  PMID: 28829397 BACKGROUND

• 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.

  PMID: 32528151 RESULT

• 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.

  PMID: 26590418 RESULT

• 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.

  PMID: 33005208 RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Gisèle Pichering, Pr

  Centre d'Investigation Clinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Polakof, Ph D

CONTACT

+33473624895; sergio.polakof@inrae.fr

Claudine Manach, Ph D

CONTACT

+33473624826; claudine.manach@inrae.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: December 11, 2023
• Study Start: February 14, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

FR (3)