Nursing HomesMAÏANCT05628155
MAÏA - MAintain the Level of Independence Through Alimentation
A study testing Oral diet including n-3 PUFA intake in people with Nursing Homes and Clinical Trial, run by Rennes University Hospital at 1 site in France.
Trial summary
Malnutrition has serious consequences: increased risk of falls, hospitalization and mortality. Malnutrition may accompany or aggravate another geriatric syndrome. The loss of muscle mass and function, called "sarcopenia" can itself lead to a loss of physical activity and therefore of independence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Homes, Clinical Trial, Food
- What is being tested?
- Oral diet including n-3 PUFA intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2022to 15 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents in permanent accommodation in participating nursing homes during the inclusion period;
- Residents in accommodation in nursing homes with similar catering services and who are not supplied with Bleu Blanc Coeur® food or who are supplied with at most 2 BBC products per week;
- Affiliation to a social security scheme;
- Consent signed by the resident or the person in charge of the representative
Who cannot join
- ADL-LFS score on inclusion >19;
- Exclusive enteral nutrition;
- Protection of effective justice;
- Lack of understanding of the French language;
- Estimated life expectancy of less than 12 months on inclusion, estimated by the attending physician or, if there is one, the nursing home physician.
- Only for the ancillary actimetry study: residents under guardianship or unable to self-manage.
Trial locations and contacts
1 site in 1 country.
About this study
Malnutrition has serious consequences: increased risk of falls, hospitalization and mortality. Malnutrition may accompany or aggravate another geriatric syndrome. The loss of muscle mass and function, called "sarcopenia" can itself lead to a loss of physical activity and therefore of independence.
It has been reported that changes in the quantity or quality of food intake could influence the onset or progression of sarcopenia. Thus, an optimized oral diet covering the energy and protein needs of the elderly people living in a nursing home is a key element of the malnutrition prevention strategy. It could help slow down the loss of independence and have a direct impact on the occurrence of the complications mentioned above, and therefore on the use of care.
Read more
In the elderly, as in the general population, the consumption of linoleic acid (LA), precursor of the omega 6 line, is too high, and that of alpha-linolenic acid (ALA), precursor of the omega 3 line, insufficient. The French National Institute against Cancer (INCA) 3 survey results indicate for the 65-79 year old population average ALA intakes of 0.9 g/d whereas the recommendation is 2 g/d. The same is true for long-chain n-3 PUFAs (eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA)).
There are currently no recommendations specifically concerning nursing home populations. Only recommendations for non-frail people, over the age of 65, exist (ANSES, 2019). Experts recommend maintaining or even slightly increasing the consumption of portions of meat, eggs, fish, fruits and vegetables and dairy products.
In the elderly, as in adults, an imbalance of n-6/n-3 PUFA intake or insufficient n-3 PUFA intake could facilitate the occurrence of cardiovascular diseases and certain cancers. The possible prevention of other pathologies more specific to the elderly, such as degenerative diseases, makes the consumption of n-3 PUFAs relevant in this population.
Our approach aiming to cover the recommended dietary allowances (RDA) of n-3 PUFAs via the oral diet is therefore very original.
An oral diet containing these different sources of fatty acid intake, of various origins, and other essential nutrients for the elderly, would have the advantage of meeting the nutritional objectives on the one hand, and of offering a wide range of tastes, flavors, and texture, allowing to optimize their consumption by nursing home residents, on the other hand. No study has yet evaluated the benefits of n-3 PUFA intake in dependent elderly people residing in nursing homes, moreover, using loss of independence as the main endpoint.
The main objective of the trial is to evaluate the effect of an everyday diet containing n-3 PUFA intakes corresponding to the RDA (population > 65 years) compared to the usual diet (therefore uncontrolled) on the evolution of the loss of independence at 2 years of nursing home residents.
Read the detailed description
Prospective, controlled, randomized, multicentre, open-label clinical study comparing two groups of residents:
- "Control" group: nursing home residents will receive an oral diet covering their nutritional needs in macronutrients as recommended for people over 70-65 years of age.
- "Intervention" group: nursing home residents will receive an oral diet covering their nutritional needs in macronutrients as recommended for people over 65-70 years of age and including n-3 PUFA intake corresponding to the RDAs for people over 65 years.
Residents will be included in clusters corresponding to the nursing homes in which they reside.
The intervention will be delivered "at the nursing home level", i.e. all the residents included in the same nursing home will belong to the same "control" or "intervention" group.
Notes: Note that a randomization of residents across the individual residents was not possible from a logistical point of view in a context of collective feeding in an institution.
Actimetry analyzes as a marker of frailty. The investigators will conduct an ancillary study of actimetry analysis, on a sub-population of 60 residents (n=30 per group), in order to quantify physical activity and try to identify a possible trajectory of frailty that The investigators can correlate to the studied endpoints. To do this, the investigators will have a device consisting of an accelerometer and a barometer which will be positioned in a case around the neck (pendant) or failing that - if the resident expresses a preference - on the wrist (bracelet) to monitor participants' activities for 24 months. The nursing homes concerned will be selected for their proximity to Rennes and the homogeneity of the physical activities routinely offered to residents. The measures will be performed one week per month for 24 months.
Main judgment criterion: Measurement of the level of independence by the ADL-LFS (Activities of Daily Living - Long Form Score) at 2 years from the RAI-MDS 3.0 questionnaire (Resident Assessment Instrument Minimum Dataset) LTCF (Long-Term Care Facilities).
Secondary endpoints:
Evaluate the effect of an everyday diet containing n-3 PUFA intakes corresponding to the RDA (population > 65 years) compared to the usual diet (therefore uncontrolled) on the following endpoints:
- The evolution of anthropometric criteria and malnutrition
- The risk of falling
- The risk of an infection occurring
- The evolution of the quality of life
- Mortality
- Healthcare consumption (hospitalizations and visits to the emergency room)
- In a sub-population of 60 residents (n=30 per group) randomly selected among the participants of a few volunteer nursing homes and meeting the inclusion and non-inclusion criteria of the study.
- The evolution of the quality of physical and sporting activity
- The evolution of the quality of sleep Organic:
- The biological profile of blood fatty acids and concentrations of ALA, EPA, DPA, DHA in red blood cells
- Micro-CRP and albumin
- Evaluation of the cost of implementing the nutritional intervention from the perspective of nursing homes vs the clinical benefits
- Conditions
- Nursing Homes, Clinical Trial, Food
- Being tested
- Oral diet including n-3 PUFA intake
- Keywords
- elderly, nursing homes, omega-3 polyunsaturated fatty acids, malnutrition, sarcopenia.
- Medical subject headings
- Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral diet including n-3 PUFA intakeOther
menus to cover the recommended intake of n-3 PUFAs (ALA =1% of total energy intake, i.e. 2.1 g/d, and EPA+DHA = 500 mg/d) (n-3 PUFA MENU), based on mass-market products that guarantee the n-3 PUFA RDAs and are available from the catering sector
| Study group | Role | What they receive |
|---|---|---|
| Oral diet including n-3 PUFA intake | Experimental | Oral diet covering the nutritional requirements in macronutrients as recommended for people over 65 years of age (ANSES, 2019) and including intakes of n-3 PUFAs corresponding to the recommendations for people over 65 years of age Receives: Other: Oral diet including n-3 PUFA intake |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
independence level
Measurement of independence level of by the ADL-LFS (Activities of Daily Living - Long Form Score) at 2 years. The evaluation criterion used is the functional numerical scale from 0 to 28 (0 = independent, 28= total dependence)
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start5 Dec 2022
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing HomesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronan THIBAULT, MD, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628155
- Sponsor's protocol ID
- 35RC21_9884_MAÏA
- Acronym
- MAÏA
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Billy C, Bajeux E, Mairesse G, Charras K, Weill P, Somme D, Thibault R. The MAIA trial: Protocol of a prospective randomized controlled trial to evaluate the impact of an omega-3 polyunsaturated fatty acids-enriched diet on the loss of independence in nursing home residents. Clin Nutr ESPEN. 2026 Jun;73:103302. doi: 10.1016/j.clnesp.2026.103302. Epub 2026 Apr 20.
PubMed 42019884
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAÏA - MAintain the Level of Independence Through Alimentation
- ClinicalTrials.gov ID
- NCT05628155
- Acronym / sponsor ID
- MAÏA / 35RC21_9884_MAÏA
- Conditions
- Nursing Homes, Clinical Trial, Food
- Keywords
- elderly, nursing homes, omega-3 polyunsaturated fatty acids, malnutrition, sarcopenia.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 28 Nov 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.
Malnutrition has serious consequences: increased risk of falls, hospitalization and mortality. Malnutrition may accompany or aggravate another geriatric syndrome. The loss of muscle mass and function, called "sarcopenia" can itself lead to a loss of physical activity and therefore of independence.
It has been reported that changes in the quantity or quality of food intake could influence the onset or progression of sarcopenia. Thus, an optimized oral diet covering the energy and protein needs of the elderly people living in a nursing home is a key element of the malnutrition prevention strategy. It could help slow down the loss of independence and have a direct impact on the occurrence of the complications mentioned above, and therefore on the use of care.
In the elderly, as in the general population, the consumption of linoleic acid (LA), precursor of the omega 6 line, is too high, and that of alpha-linolenic acid (ALA), precursor of the omega 3 line, insufficient. The French National Institute against Cancer (INCA) 3 survey results indicate for the 65-79 year old population average ALA intakes of 0.9 g/d whereas the recommendation is 2 g/d. The same is true for long-chain n-3 PUFAs (eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA)).
There are currently no recommendations specifically concerning nursing home populations. Only recommendations for non-frail people, over the age of 65, exist (ANSES, 2019). Experts recommend maintaining or even slightly increasing the consumption of portions of meat, eggs, fish, fruits and vegetables and dairy products.
In the elderly, as in adults, an imbalance of n-6/n-3 PUFA intake or insufficient n-3 PUFA intake could facilitate the occurrence of cardiovascular diseases and certain cancers. The possible prevention of other pathologies more specific to the elderly, such as degenerative diseases, makes the consumption of n-3 PUFAs relevant in this population.
Our approach aiming to cover the recommended dietary allowances (RDA) of n-3 PUFAs via the oral diet is therefore very original.
An oral diet containing these different sources of fatty acid intake, of various origins, and other essential nutrients for the elderly, would have the advantage of meeting the nutritional objectives on the one hand, and of offering a wide range of tastes, flavors, and texture, allowing to optimize their consumption by nursing home residents, on the other hand. No study has yet evaluated the benefits of n-3 PUFA intake in dependent elderly people residing in nursing homes, moreover, using loss of independence as the main endpoint.
The main objective of the trial is to evaluate the effect of an everyday diet containing n-3 PUFA intakes corresponding to the RDA (population > 65 years) compared to the usual diet (therefore uncontrolled) on the evolution of the loss of independence at 2 years of nursing home residents.
Detailed description
Prospective, controlled, randomized, multicentre, open-label clinical study comparing two groups of residents:
- "Control" group: nursing home residents will receive an oral diet covering their nutritional needs in macronutrients as recommended for people over 70-65 years of age.
- "Intervention" group: nursing home residents will receive an oral diet covering their nutritional needs in macronutrients as recommended for people over 65-70 years of age and including n-3 PUFA intake corresponding to the RDAs for people over 65 years.
Residents will be included in clusters corresponding to the nursing homes in which they reside.
The intervention will be delivered "at the nursing home level", i.e. all the residents included in the same nursing home will belong to the same "control" or "intervention" group.
Notes: Note that a randomization of residents across the individual residents was not possible from a logistical point of view in a context of collective feeding in an institution.
Actimetry analyzes as a marker of frailty. The investigators will conduct an ancillary study of actimetry analysis, on a sub-population of 60 residents (n=30 per group), in order to quantify physical activity and try to identify a possible trajectory of frailty that The investigators can correlate to the studied endpoints. To do this, the investigators will have a device consisting of an accelerometer and a barometer which will be positioned in a case around the neck (pendant) or failing that - if the resident expresses a preference - on the wrist (bracelet) to monitor participants' activities for 24 months. The nursing homes concerned will be selected for their proximity to Rennes and the homogeneity of the physical activities routinely offered to residents. The measures will be performed one week per month for 24 months.
Main judgment criterion: Measurement of the level of independence by the ADL-LFS (Activities of Daily Living - Long Form Score) at 2 years from the RAI-MDS 3.0 questionnaire (Resident Assessment Instrument Minimum Dataset) LTCF (Long-Term Care Facilities).
Secondary endpoints:
Evaluate the effect of an everyday diet containing n-3 PUFA intakes corresponding to the RDA (population > 65 years) compared to the usual diet (therefore uncontrolled) on the following endpoints:
- The evolution of anthropometric criteria and malnutrition
- The risk of falling
- The risk of an infection occurring
- The evolution of the quality of life
- Mortality
- Healthcare consumption (hospitalizations and visits to the emergency room)
- In a sub-population of 60 residents (n=30 per group) randomly selected among the participants of a few volunteer nursing homes and meeting the inclusion and non-inclusion criteria of the study.
- The evolution of the quality of physical and sporting activity
- The evolution of the quality of sleep Organic:
- The biological profile of blood fatty acids and concentrations of ALA, EPA, DPA, DHA in red blood cells
- Micro-CRP and albumin
- Evaluation of the cost of implementing the nutritional intervention from the perspective of nursing homes vs the clinical benefits
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral diet including n-3 PUFA intake | Experimental | Other: Oral diet including n-3 PUFA intakeOral diet covering the nutritional requirements in macronutrients as recommended for people over 65 years of age (ANSES, 2019) and including intakes of n-3 PUFAs corresponding to the recommendations for people over 65 years of age |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Residents in permanent accommodation in participating nursing homes during the inclusion period;
- Residents in accommodation in nursing homes with similar catering services and who are not supplied with Bleu Blanc Coeur® food or who are supplied with at most 2 BBC products per week;
- Affiliation to a social security scheme;
- Consent signed by the resident or the person in charge of the representative
Key exclusion criteria (6 listed)
- ADL-LFS score on inclusion >19;
- Exclusive enteral nutrition;
- Protection of effective justice;
- Lack of understanding of the French language;
- Estimated life expectancy of less than 12 months on inclusion, estimated by the attending physician or, if there is one, the nursing home physician.
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 |
|---|---|---|
| Oral diet including n-3 PUFA intakemenus to cover the recommended intake of n-3 PUFAs (ALA =1% of total energy intake, i.e. 2.1 g/d, and EPA+DHA = 500 mg/d) (n-3 PUFA MENU), based on mass-market products that guarantee the n-3 PUFA RDAs and are available from the catering sector | Other | Oral diet including n-3 PUFA intake |
Primary outcome
independence level
Time frame: at 2 years
Measurement of independence level of by the ADL-LFS (Activities of Daily Living - Long Form Score) at 2 years. The evaluation criterion used is the functional numerical scale from 0 to 28 (0 = independent, 28= total dependence)
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 17 Jun 2026.
- Derived from this study: PubMed 42019884Billy C, Bajeux E, Mairesse G, Charras K, Weill P, Somme D, Thibault R. The MAIA trial: Protocol of a prospective randomized controlled trial to evaluate the impact of an omega-3 polyunsaturated fatty acids-enriched diet on the loss of independence in nursing home residents. Clin Nutr ESPEN. 2026 Jun;73:103302. doi: 10.1016/j.clnesp.2026.103302. Epub 2026 Apr 20.
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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.
Ronan THIBAULT, MD, PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral diet including n-3 PUFA intake in people with Nursing Homes and Clinical Trial, run by Rennes University Hospital 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 4 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: finished, as of the sponsor's last update on 17 Jun 2026. 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?
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?
independence level (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628155, which also lists 1 linked publication.
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 17 Jun 2026.