Improving independence in nursing home residents through optimized nutrition
MAÏA - MAintain the Level of Independence Through Alimentation
This study is testing if a special diet with omega-3s can help nursing home residents who are struggling with malnutrition and muscle loss feel more independent compared to a standard diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 456 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT05628155 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to address malnutrition and sarcopenia among elderly residents in nursing homes by comparing two dietary interventions. One group will receive a standard diet, while the other will receive a diet enriched with omega-3 polyunsaturated fatty acids (n-3 PUFA) tailored to their nutritional needs. The study will be conducted in a controlled, randomized, multicenter format, with residents grouped by their nursing home. Additionally, an ancillary study will analyze physical activity levels using actimetry to assess frailty trajectories in a subset of participants.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly residents living in nursing homes who are at risk of malnutrition and sarcopenia.
Not a fit: Patients who are already receiving exclusive enteral nutrition or have a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the nutritional status and independence of elderly nursing home residents, reducing the risk of falls and hospitalizations.
How similar studies have performed: Previous studies have indicated that dietary interventions can positively impact malnutrition and sarcopenia in elderly populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Rennes
- Les jardins d'Hermine — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Ronan THIBAULT, MD, PhD — Rennes University Hospital
- Study coordinator: Ronan THIBAULT, MD, PhD
- Email: ronan.thibault@chu-rennes.fr
- Phone: 02.99.28.96.46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.