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"

Обзор

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.

Вмешательства

• Биопрепарат Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data
  at T0, T3 months, T6 months, T9 months and T12 months
• Другое Body Mass Index (BMI)
  Calculation of BMI with height measurement by heel-knee distance measurement at T0, T3 months, T6 months, T9 months and T12 months
• Другое 24-hour food and beverage record
  at T0, T3 months, T6 months, T9 months and T12 months
• Другое Mini Nutritional assessment (MNA)
  at T0, T3 months, T6 months, T9 months and T12 months
• Другое Measurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker)
  at T0, T3 months, T6 months, T9 months and T12 months
• Другое Measurement of sensorimotor functions
  at T0, T3 months, T6 months, T9 months and T12 months
• Другое Measurement of cognitive functions
  at T0, T3 months, T6 months, T9 months and T12 months

Первичные конечные точки

• Measurement of the alpha diversity of the microbiota and the intestinal mycobiota [Срок оценки: up to T12 months]
• Measurement of the beta diversity of the microbiota and the intestinal mycobiota [Срок оценки: up to T12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Chu Dijon Bourgogne — Dijon

Идентификаторы

NCT: NCT05449119 · DALLE CHU 2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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