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

BACKGROUND: Malnutrition and frailty are prevalent issues in nursing homes, leading to increased dependence and morbidity. N-3 polyunsaturated fatty acids (PUFAs), i.e. linolenic, eicosapentaenoic, and docosahexaenoic acids, have demonstrated potential benefits in mitigating inflammation, cognitive decline, and sarcopenia. However, there is limited evidence on the impact of dietary n-3 PUFAs enrichment in preventing independence loss in the older patients and particularly nursing home (NH) residents. OBJECTIVES: The trial aims to evaluate whether an n-3 PUFAs-enriched diet to cover the recommended daily allowance needs can slow down the decline in independence among older residents in NH. METHODS: A prospective, randomized, controlled, open-label, multicenter trial will be conducted in NH. The study population (n = 432) will be cluster-randomized into two groups: 1- an intervention group receiving an n-3 PUFAs enriched diet, and 2- a control group receiving the usual institutional diet. The primary outcome will be the change in independence, measured by the Activities of Daily Living-Long Form Score (ADL-LFS) at 24 months. Secondary outcomes will include ADL-LFS at 6, 12, and 18 months, nutritional status, body composition, muscle function, fall incidence, infection rates, cognitive function, depression scale, n-3 and n-6 PUFAs blood levels, and healthcare resource utilization. In a subgroup of patients (n = 30 per group), data on actimetry will be collected. Statistical analyses will be conducted using a generalized linear mixed model to account for clustering effects. CONCLUSION: This trial will assess whether an n-3 PUFAs enriched diet has the potential to slow the loss of independence in NH residents. The findings could have potential implications for nutritional policies in NH and clinical guidelines. TRIAL REGISTRATION: NCT05628155 (clinicaltrials.gov). ETHICAL APPROVAL: CPP Île de France X, on January 12, 2023, under the number #2022-A00850-43.