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"

NCT05449119 | Recruiting

• 1 other identifier: DALLE CHU 2020
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Small Eater

Outcome Measures

Primary Outcomes (2)

• Measurement of the alpha diversity of the microbiota and the intestinal mycobiota

  Measure indicating the diversity of a single sample

  up to T12 months

• Measurement of the beta diversity of the microbiota and the intestinal mycobiota

  Measure of species diversity between samples

  up to T12 months

Study Arms (2)

Non small eaters

Elderly subjects who are not malnourished

Biological: Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data; Other: Body Mass Index (BMI); Other: 24-hour food and beverage record; Other: Mini Nutritional assessment (MNA); Other: Measurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker); Other: Measurement of sensorimotor functions; Other: Measurement of cognitive functions

Small eaters

Elderly subjects with loss of appetite

Biological: Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data; Other: Body Mass Index (BMI); Other: 24-hour food and beverage record; Other: Mini Nutritional assessment (MNA); Other: Measurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker); Other: Measurement of sensorimotor functions; Other: Measurement of cognitive functions

Interventions

Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data BIOLOGICAL

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

Non small eaters; Small eaters

Body Mass Index (BMI) OTHER

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

Non small eaters; Small eaters

24-hour food and beverage record OTHER

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

Non small eaters; Small eaters

Mini Nutritional assessment (MNA) OTHER

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

Non small eaters; Small eaters

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

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

Non small eaters; Small eaters

Measurement of sensorimotor functions OTHER

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

Non small eaters; Small eaters

Measurement of cognitive functions OTHER

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

Non small eaters; Small eaters

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly people over 75 years old residing in EHPAD with a loss of appetite or not malnourished.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Interventions

Defecation; Blood Specimen Collection; Body Mass Index; Food; Nutrition Assessment

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Body Weights and Measures; Body Constitution; Physical Examination; Anthropometry; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health; Diet, Food, and Nutrition; Food and Beverages; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Frédéric DALLE

CONTACT

0380295014; frederic.dalle@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 8, 2022
• Study Start: June 13, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

FR (1)