MAÏA - MAintain the Level of Independence Through Alimentation

NCT05628155 | Unknown

• 1 other identifier: 35RC21_9884_MAÏA
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

elderly; nursing homes; omega-3 polyunsaturated fatty acids; malnutrition; sarcopenia.

Outcome Measures

Primary Outcomes (1)

• 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)

  at 2 years

Study Arms (2)

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

Other: Oral diet including n-3 PUFA intake

Control

NO INTERVENTION

Interventions

Oral diet including n-3 PUFA intake OTHER

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

Oral diet including n-3 PUFA intake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Exclusive enteral nutrition;
• Protection of effective justice;
• Lack of understanding of the French language;
• Only for the ancillary actimetry study: residents under guardianship or unable to self-manage.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Les jardins d'Hermine

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Malnutrition; Sarcopenia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Ronan THIBAULT, MD, PhD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronan THIBAULT, MD, PhD

CONTACT

02.99.28.96.46; ronan.thibault@chu-rennes.fr

Kristell COAT

CONTACT

0299282555; kristell.coat@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: December 5, 2022
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

FR (1)