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Loss of Autonomy in the Elderly: Relationships Between Gut Microbiota Diversity, Nutrition and Cognitive and Sensory-motor Disturbances in Small Eaters and Non Small Eaters

Loss of Autonomy in the Elderly: Relationships Between Gut Microbiota Diversity, Nutrition and Cognitive and Sensory-motor Disturbances in Small Eaters and Non Small Eaters

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05449119
Acronym
ALMICO
Enrollment
140
Registered
2022-07-08
Start date
2023-06-13
Completion date
2028-06-30
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly Small Eater

Brief summary

Older adults currently make up 25% of the population in France, and future health expenditures will be largely related to the consequences of aging. Normal aging is associated with a progressive decrease in cognitive and sensorimotor function, malnutrition and/or under-nutrition and intestinal dysbiosis (i.e. changes in the composition and/or stability of the microbiota). Furthermore, admission to long-term care facilities such as Etablissement d'Hébergement pour Personnes Agées Dépendantes (EHPAD) leads to drastic changes in lifestyle in terms of (i) nutrition and (ii) motor functions. These modifications can influence the composition of the intestinal microbiota and its temporal evolution. We will study the relationship between the deterioration of cognitive and sensorimotor function, diet and intestinal well-being (i.e. microbiota) of a cohort of older adults (\>75 years) defined as small eaters from their admission in EHPAD at the University Hospital of Dijon. This study will be carried out by a unique French multidisciplinary consortium that includes academics and health professionals, who will be able to specify the criteria defining the small eaters and to envisage suitable dietary strategies aiming to preserve their nutritional status and intestinal well-being. The final goal is to improve quality of life at home by prolonging autonomy and independence, and thus to deferring admission to an EHPAD for as long as possible. The objective of this study is to build a cohort of elderly small eaters and a cohort of elderly non small eaters. These patients will be followed over a period of one year. The evolution of the composition of the intestinal microbiota will be determined in order to establish the existing relations between the composition of digestive microbiota, the nutritional state, and cognitive and sensorimotor function.

Interventions

BIOLOGICALFecal and blood sampling and collection of nutritional, cognitive and sensorimotor data

at T0, T3 months, T6 months, T9 months and T12 months

Calculation of BMI with height measurement by heel-knee distance measurement at T0, T3 months, T6 months, T9 months and T12 months

OTHER24-hour food and beverage record

at T0, T3 months, T6 months, T9 months and T12 months

OTHERMini Nutritional assessment (MNA)

at T0, T3 months, T6 months, T9 months and T12 months

OTHERMeasurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker)

at T0, T3 months, T6 months, T9 months and T12 months

OTHERMeasurement of sensorimotor functions

at T0, T3 months, T6 months, T9 months and T12 months

OTHERMeasurement of cognitive functions

at T0, T3 months, T6 months, T9 months and T12 months

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Person who has given oral consent and has not objected to being included in the study, or if necessary, oral consent of an appointed legal representative. * A person over 75 years of age residing in an EHPAD who may be under guardianship or curatorship. * A person over 75 years of age with a loss of appetite (i.e. a small eater) residing in an EHPAD, who may be under guardianship or curatorship.

Exclusion criteria

* Person not affiliated to national health insurance * Elderly person with an infectious syndrome at the time of admission; * Elderly person with diarrhoea (infectious or not) at the time of admission; * Elderly person receiving recently prescribed antimicrobials at the time of admission (antibiotics or antifungals) * Elderly person with celiac disease and/or Crohn's disease. * Person under a measure of limited judicial protection

Design outcomes

Primary

MeasureTime frameDescription
Measurement of the alpha diversity of the microbiota and the intestinal mycobiotaup to T12 monthsMeasure indicating the diversity of a single sample
Measurement of the beta diversity of the microbiota and the intestinal mycobiotaup to T12 monthsMeasure of species diversity between samples

Countries

France

Contacts

Primary ContactFrédéric DALLE
frederic.dalle@chu-dijon.fr0380295014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026