Nutrition DisordersNutridentNCT00873717
Improvement of Nutritional Status in Elderly Residents of Long-term Facilities
A study testing Dentary, Nutrition and Dentary + Nutrition in people with Nutrition Disorders, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
Trial summary
Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- Dentary, Nutrition and Dentary + Nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Geriatric Nutritional Risk Index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay
Who cannot join
- refusal to participate in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre gérontologie Les Abondances
Boulogne-Billancourt, Île-de-France Region, 92100
Institut ROGUET
Clichy, Île-de-France Region, 92
AP-HP, Louis Mourier Hospital
Colombes, Île-de-France Region, 92700
Hôpital Bretonneau
Paris, Île-de-France Region, 75018
Hôpital de Puteaux
Puteaux, Île-de-France Region, 92
AP-HP, Hôpital René Muret-Bigottini
Sevran, Île-de-France Region, 93
About this study
Official title: Improvement of Nutritional Status in Elderly Residents of Long-term Facilities: Impact of Two Strategies (Oral Care and Dietary Control)
Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. The impact of a rehabilitation of dental function on their nutritional status has not been proven.
The objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.
Read the detailed description
Two interventions are evaluated during a 1 year study period, with a 4 arms factorial design.
The "Dentary" intervention implies a trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.
The "Nutrition" intervention consists in 1) comparing the meals and oral supplements administered with the dietary prescriptions and 2) Incite patients to eat.
- Conditions
- Nutrition Disorders
- Being tested
- Dentary, Nutrition, Dentary + Nutrition
- Keywords
- elderly, long-term facilities, nutritional status
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DentaryOther
cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).
NutritionOther
control of the administration of dietary prescriptions, incitement to eat.
Dentary + NutritionOther
Also called Dentary and Nutrition
trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.
associated with control of the administration of dietary prescriptions, incitement to eat.
| Study group | Role | What they receive |
|---|---|---|
| Dentary | Experimental | Intervention: trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash. Receives: Other: Dentary |
| Nutrition | Experimental | control of the administration of dietary prescriptions, incitement to eat. Receives: Other: Nutrition |
| Dentary + nutrition | Experimental | cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed) associated with control of the administration of dietary prescriptions, incitement to eat. Receives: Other: Dentary + Nutrition |
| Control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of GNRI mean-score between arms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CHARRU, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisMarysette FOLLIGUET, DDS, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873717
- Sponsor's protocol ID
- AOM07055
- Other IDs
- K070103, 2008-A00039-46
- Acronym
- Nutrident
- Status last verified
- Apr 2009
- First submitted
- 1 Apr 2009
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Nutritional Status in Elderly Residents of Long-term Facilities: Impact of Two Strategies (Oral Care and Dietary Control)
- ClinicalTrials.gov ID
- NCT00873717
- Acronym / sponsor ID
- Nutrident / AOM07055
- Conditions
- Nutrition Disorders
- Keywords
- elderly, long-term facilities, nutritional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Apr 2009 (estimated)
- 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.
Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. The impact of a rehabilitation of dental function on their nutritional status has not been proven.
The objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.
Detailed description
Two interventions are evaluated during a 1 year study period, with a 4 arms factorial design.
The "Dentary" intervention implies a trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.
The "Nutrition" intervention consists in 1) comparing the meals and oral supplements administered with the dietary prescriptions and 2) Incite patients to eat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dentary | Experimental | Other: DentaryIntervention: trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash. |
| Nutrition | Experimental | Other: Nutritioncontrol of the administration of dietary prescriptions, incitement to eat. |
| Dentary + nutrition | Experimental | Other: Dentary + Nutritioncleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed) associated with control of the administration of dietary prescriptions, incitement to eat. |
| Control | No intervention | –usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Geriatric Nutritional Risk Index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay
Key exclusion criteria (1 listed)
- refusal to participate in the study
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 |
|---|---|---|
| Dentarycleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed). | Other | Dentary |
| Nutritioncontrol of the administration of dietary prescriptions, incitement to eat. | Other | Nutrition |
| Dentary + NutritionAlso: Dentary and Nutritiontrimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash. associated with control of the administration of dietary prescriptions, incitement to eat. | Other | Dentary + nutrition |
Primary outcome
comparison of GNRI mean-score between arms
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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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. This study is not recruiting at the moment.
Philippe CHARRU, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Marysette FOLLIGUET, DDS study chair
Assistance Publique - Hôpitaux de Paris
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dentary, Nutrition and Dentary + Nutrition in people with Nutrition Disorders, run by Assistance Publique - Hôpitaux de Paris at 6 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of GNRI mean-score between arms (time frame: 1 year). 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 26 Jul 2012.