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

Overview

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 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.

Interventions

• Other Nutritional postprandial test
  Metabolic responses to several test meals

Primary outcome measures

• Characterize the inter-individual variability of the blood glucose postprandial response [Time frame: Within the first month of study realization]

Secondary outcome measures (12)

• Questionnaires about food habits and preferences (with a special focus on polyphenols) [Time frame: Within the three months of study realization]
• Test to assess taste abilities [Time frame: Within the first week of study realization]
• Test to assess olfactory abilities [Time frame: Within the first week of study realization]
• Time to walk 4 meters [Time frame: Within the first two months of study realization]
• Time to stand up 5 times from a chair [Time frame: Within the first two months of study realization]
• Maximum tolerated muscle power [Time frame: Within the first two months of study realization]
• Maximal isometric strength [Time frame: Within the first two months of study realization]
• Questionnaires about usual physical activity [Time frame: Within the first two months of study realization]
• Measurement of total body lean mass (kg) [Time frame: Within the first two months of study realization]
• Measurement of total body fat mass (kg) [Time frame: Within the first two months of study realization]
• Measurement of peripheral endothelial function (RHI, %) [Time frame: Within the first week of study realization]
• Measurement of microvascular stiffness (Augmentation Index) [Time frame: Within the first week of study realization]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

France · 3 centers

• Pic / Cic-Inserm 1405 — Clermont-Ferrand
• Plateforme d'Exploration de la Mobilité (CHU Clermont-Ferrand) — Clermont-Ferrand
• Centre de Recherche en Odontologie Clinique, Faculté de Chirurgie Dentaire — Clermont-Ferrand

Publications

• 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
• 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
• 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
• 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/s415 PMID 32528151
• 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
• 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

Identifiers

NCT: NCT06163794 · INRAE-UNH-2023-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗