Elderly Small EaterALMICONCT05449119
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"
An observational study of Elderly Small Eater, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elderly Small Eater
- What is being tested?
- Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data, Body Mass Index (BMI) and 24-hour food and beverage record
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jun 2023to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly people over 75 years old residing in EHPAD with a loss of appetite or not malnourished.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Frédéric DALLE, 0380295014, frederic.dalle@chu-dijon.fr
About this study
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
- Being tested
- Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor data, Body Mass Index (BMI), 24-hour food and beverage record, Mini Nutritional assessment (MNA), Measurement of muscle mass by bioelectrical impedance analysis (except for participants with a pacemaker)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor dataBiological
at T0, T3 months, T6 months, T9 months and T12 months
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
24-hour food and beverage recordOther
at T0, T3 months, T6 months, T9 months and T12 months
Mini Nutritional assessment (MNA)Other
at T0, T3 months, T6 months, T9 months and T12 months
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
Measurement of sensorimotor functionsOther
at T0, T3 months, T6 months, T9 months and T12 months
Measurement of cognitive functionsOther
at T0, T3 months, T6 months, T9 months and T12 months
| Study group | Role | What they receive |
|---|---|---|
| Non small eaters | Elderly subjects who are not malnourished Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the alpha diversity of the microbiota and the intestinal mycobiota
Measure indicating the diversity of a single sample
Measured: up to T12 months
Measurement of the beta diversity of the microbiota and the intestinal mycobiota
Measure of species diversity between samples
Measured: up to T12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start13 Jun 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Small EaterStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449119
- Sponsor's protocol ID
- DALLE CHU 2020
- Acronym
- ALMICO
- Status last verified
- Aug 2024
- First submitted
- 4 Jul 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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"
- ClinicalTrials.gov ID
- NCT05449119
- Acronym / sponsor ID
- ALMICO / DALLE CHU 2020
- Conditions
- Elderly Small Eater
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non small eaters | – | 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 functionsElderly subjects who are not malnourished |
| Small eaters | – | 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 functionsElderly subjects with loss of appetite |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly people over 75 years old residing in EHPAD with a loss of appetite or not malnourished.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal and blood sampling and collection of nutritional, cognitive and sensorimotor dataat T0, T3 months, T6 months, T9 months and T12 months | Biological | Non small eaters, Small eaters |
| 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 | Non small eaters, Small eaters |
| 24-hour food and beverage recordat T0, T3 months, T6 months, T9 months and T12 months | Other | Non small eaters, Small eaters |
| Mini Nutritional assessment (MNA)at T0, T3 months, T6 months, T9 months and T12 months | Other | Non small eaters, Small eaters |
| 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 | Non small eaters, Small eaters |
| Measurement of sensorimotor functionsat T0, T3 months, T6 months, T9 months and T12 months | Other | Non small eaters, Small eaters |
| Measurement of cognitive functionsat T0, T3 months, T6 months, T9 months and T12 months | Other | Non small eaters, Small eaters |
Primary outcome
Measurement of the alpha diversity of the microbiota and the intestinal mycobiota
Time frame: up to T12 months
Measure indicating the diversity of a single sample
Measurement of the beta diversity of the microbiota and the intestinal mycobiota
Time frame: up to T12 months
Measure of species diversity between samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Small Eater, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric DALLE (0380295014, frederic.dalle@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the alpha diversity of the microbiota and the intestinal mycobiota (time frame: up to T12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.