Trials / Recruiting
RecruitingNCT05449119
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 140 (estimated)
- Sponsor
- Centre Hospitalier Universitaire Dijon · Academic / Other
- Sex
- All
- Age
- 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data | at T0, T3 months, T6 months, T9 months and T12 months |
| OTHER | 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 |
| OTHER | 24-hour food and beverage record | at T0, T3 months, T6 months, T9 months and T12 months |
| OTHER | Mini Nutritional assessment (MNA) | at T0, T3 months, T6 months, T9 months and T12 months |
| OTHER | 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 |
| OTHER | Measurement of sensorimotor functions | at T0, T3 months, T6 months, T9 months and T12 months |
| OTHER | Measurement of cognitive functions | at T0, T3 months, T6 months, T9 months and T12 months |
Timeline
- Start date
- 2023-06-13
- Primary completion
- 2028-06-01
- Completion
- 2028-06-01
- First posted
- 2022-07-08
- Last updated
- 2024-08-15
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05449119. Inclusion in this directory is not an endorsement.