MAÏA - MAintain the Level of Independence Through Alimentation

NCT05628155 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2023-04-13

No results posted yet for this study

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.

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.

Conditions

  • Nursing Homes
  • Clinical Trial
  • Food

Interventions

OTHER

Oral diet including n-3 PUFA intake

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

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Ronan THIBAULT, MD, PhD · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2025-06-05
Completion
2025-06-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628155 on ClinicalTrials.gov