Nutritional Programme for Dementia Elderly Patient

NCT ID: NCT00479843

Last Updated: 2014-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

946 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme.

The secondary objectives are the improvement of the state of nutrition, a reduction in the use of resources and a reduction in the burden on the main carer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Main objective The main objective of this project is the evaluation of the effectiveness of a nutrition programme in patients with Alzheimer's or other dementias. Through the Nutrition Programme the idea is to reduce functional and weight loss in elderly people with cognitive deterioration and their families.

Evaluation of the effectiveness of the intervention

-The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

Secondary objectives

The secondary objectives of this study are:

* Improvement in the patient's state of nutrition The measurement criteria which will allow the patient's nutritional state to be evaluated will be their weight, BMI and MNA.
* Reducing the burden on carers. The Zarit scale will be used for this evaluation.
* Evaluation of the use of healthcare and social resources. The RUD scale will be used.
* Improvement of medical practice regarding nutrition.
* Evaluation of the representatives of our population with regard to the participation in a programme of these characteristics evaluating.
* Evaluation of the satisfaction of elderly people and their families in relation to the programme.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutritional programme

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patient has dementia according to DSM IV criteria.
* The patient has an MMSE less than or equal to 26.
* The patient lives in his/her home.
* The patient is in the charge of a carer.
* Informed consent for participation in the study by the responsible relative and, if possible, from the patient or legal guardian.

Exclusion Criteria

* The patient lives in an institution.
* The patient is in a terminal situation.
* The patient does not have a main carer.
* Patient has a nasogastric feed.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut Català de l'envelliment, Barcelona, Spain

UNKNOWN

Sponsor Role collaborator

Hospital Purpan

OTHER

Sponsor Role collaborator

NESTEC R&D, Switzerland

UNKNOWN

Sponsor Role collaborator

Group MAPI-NAXIS, CRO, Lyon, France

UNKNOWN

Sponsor Role collaborator

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoni SALVA, MD

Role: PRINCIPAL_INVESTIGATOR

SPAIN: Institut Català de l'envelliment

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Català de l'envelliment

Barcelona, Barcelona, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Salvà A(1) , Fernández E(2), Andrieux S(3), Schiffrin E(4), Vellas B(3), y el grupo Nutrialz. 1. Institut de l'Envelliment. Universitat Autònoma de Barcelona. 2. Service de Gerontologie Clinique. Hôpital Pourpan. Caselardit. Toulouse. France. 3. Nestle Nutrition. Vevey. Switzerland. Estado nutricional de un grupo de pacientes ambulatorios y las principales correlaciones con las variables de la valoración geriátrica: El Estudio Nutrialz.49th Congress from the spanish aging association (6-9 June 2007, Palma de Mallorca) Salvà A(1) , Fernández E(2), Andrieux S(3), Schiffrin E(4), Vellas B(3), y el grupo Nutrialz. 1. Institut de l'Envelliment. Universitat Autònoma de Barcelona. 2. Service de Gerontologie Clinique. Hôpital Pourpan. Caselardit. Toulouse. France. 3. Nestle Nutrition. Vevey. Switzerland Nutritional status for ambulatory dementia patients and its main correlation with caregivers psychosocial variables: The Nutrialz Study INTERNATIONAL ASSOCIATION OF GERONTOLOGY AND GERIATRICS VI EUROPEAN CONGRESS (5-8 July 2007, Saint Petersburg).

Reference Type RESULT

Roque M, Salva A, Vellas B. Malnutrition in community-dwelling adults with dementia (NutriAlz Trial). J Nutr Health Aging. 2013 Apr;17(4):295-9. doi: 10.1007/s12603-012-0401-9.

Reference Type DERIVED
PMID: 23538648 (View on PubMed)

Salva A, Roque M, Rojano X, Inzitari M, Andrieu S, Schiffrin EJ, Guigoz Y, Vellas B. Falls and risk factors for falls in community-dwelling adults with dementia (NutriAlz trial). Alzheimer Dis Assoc Disord. 2012 Jan-Mar;26(1):74-80. doi: 10.1097/WAD.0b013e318215ca90.

Reference Type DERIVED
PMID: 22354139 (View on PubMed)

Salva A, Andrieu S, Fernandez E, Schiffrin EJ, Moulin J, Decarli B, Rojano-i-Luque X, Guigoz Y, Vellas B; NutriAlz group. Health and nutrition promotion program for patients with dementia (NutriAlz): cluster randomized trial. J Nutr Health Aging. 2011 Dec;15(10):822-30. doi: 10.1007/s12603-011-0363-3.

Reference Type DERIVED
PMID: 22159768 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05.19.CLI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PREPA PREvention of Loss of Autonomy
NCT03667664 ACTIVE_NOT_RECRUITING NA