Clinical trial NCT04983290: Outcomes to the Nutritional Need of Patients With Parkinson's Disease
Official title: Clinical Trial to Assess the Effectiveness of the Food Plan Consisting of Products With Modified Consistency Called (Weancare-Domus) in Changing the Quality of Life in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deglutition Disorders
Parkinson Disease
Nursing
Quality of Life
Lead sponsor: University of Genova
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Locale 3 Genovese
First posted: 2021-07-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized nutraceutical clinical trial controlled with cross-over design on two groups
Primary purpose: PREVENTION

Brief summary: The intervention involves the identification of 140 patients (70 per group), fed throughout the duration of the study with the two different solutions indicated. The subject will be interviewed by identified and trained personnel in order to collect the information and data required by the study with frequency indicated for the individual evaluation sheets. The subject himself will be provided with all the contact and availability information of the referents of the firm for the purpose of requesting information or reporting events. The subject in the studio will be contacted weekly in order to evaluate the trend by the study referents, according to his availability, and personally interviewed by staff belonging to the research group.

Detailed description: Non-motor symptomatology in Parkinson's disease (PD) is related to the quality of life of patients . Malnutrition in the subject with Parkinson's is a still relevant variable that hesitates in sarcopenia and increased motor deficits in relation to loss of muscle mass and energy deficit. Guidelines from the European Society for Clinical Nutrition and Metabolism (ESPEN) recommend monitoring and implementing interventions in the presence of weight loss or body mass.

Disphagia is a syndrome common in Parkinson's patients, even in the early stages of the pathology. The study by Pflug and collaborators showed that only 5% of the patients observed were completely free from swallowing deficiency, while in 55% of subjects (66/119) aspiration or penetration of food and liquids in the airways were reported regardless of the stage of illness. Several studies, cited by Curtis and collaborators, show that the prevalence of disphagia varies between 11 and 97% of patients during the course of the disease. This condition affects both food safety, with the risk of aspiration and ab-ingestis, and malnutrition conditions, hydration deficiency, also affecting the overall survival of patients in relation to the onset of pneumonia.

From a nursing point of view, great interest has the integrated nutritional indices, easy and quick-to-use tools, which manage to determine promptly the presence and risk of malnutrition and which can be used daily in the patient's evaluation. The most suitable is the Mini Nutritional Assessment (MNA), which determines the risk of malnutrition before modification of biochemical parameters. MNA has a sensitivity of 96% and a specificity of 97%.

The adoption of scales that evaluate non-motorcycle-related symptoms helps to identify the sindromic dimension of the pathology, highlighting its components that impact the overall quality of life.

Patients who follow a level 3 and 4 modified texture diet of the IDDSI Framework scheme frequently encounter an overall reduction in energy and protein intake, determined by the way the meal is prepared in self-production, associated with an often drastic reduction in fluid intake with consequences in both systemic and specific terms for the gastrointestinal tract. Monitoring liquids introduced by subjects with swallowing deficiency is a Grade B recommendation in the ESPEN guidelines.

Disphagia is a frequent condition in the subject with Parkinson's disease, particularly in the advanced stages, recent studies begin to show a decay in the safety of swallowing and maintenance in the airway in these subjects, even in relatively early stages of the disease.

Therefore, the application of a specific nutritional program for patients with swallowing problems is recommended in the prevention of malnutrition in patients with Parkinson's disease. Previous studies showed the rapid reversibility of malnutrition in hospitalized elderly subjects with cognitive and functional impairment if enrolled in a specific nutritional program.

In view of the strong impact that eating difficulties have on the state of health of parkinson's disease patients suffering from disphagia, the widespread spread of dietary frailties related to the various degrees of disphagia and the importance that patients with slight difficulty swallowing or chewing do not develop further pathologies related to a nutritional deficit , it is necessary to study the effectiveness of specific nutritional programs developed to meet the person's need for nutrition The aim of the study is to improve the nursing-care management of Parkinson's disease patients with disphagia

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of FOIS-based disphagy or Smithard test (3 oz swallow test) (2 - 3) or previous FEES diagnosis
* classification of the functional oral intake scale (FOIS) level of disphagy in classes 4 or 5 (or levels 2-3 on specific clinical indication)
* Belonging to one of the territorial structures for the Management of Parkinson's Disease in the territory of Genoa

Exclusion Criteria:

* Terminally ill subjects for pathology
* Subjects with severe disphagia and indication to artificial nutrition (enteral/parenteral)
* Severe renal, liver and respiratory failure
* Disphagy level classifications inconsistent with inclusion criteria

Primary outcomes:
measure: Non-motor symptomatology change (Novel Non-Motor Symptoms Scale for Parkinson's Disease - NNMS)
timeFrame: 4 months
Secondary outcomes:
measure: Suction and ab-ingestis events related to textured food change (Novel Non-Motor Symptoms Scale for Parkinson's Disease - Domain 6: Gastrointestinal tract)
timeFrame: 4 months
Other outcomes:
measure: functional parameter related to malnutrition change: Gait speed
timeFrame: 4 months
measure: functional parameter related to malnutrition change: grip strength
timeFrame: 4 months
measure: functional parameter related to malnutrition change: muscle mass
timeFrame: 4 months
measure: functional parameter related to malnutrition change: Body Mass Index (BMI)
timeFrame: 4 months
measure: functional parameter related to malnutrition change: arm circumference
timeFrame: 4 months
measure: functional parameter related to malnutrition change: biomarkers
timeFrame: 4 months
measure: functional parameter related to malnutrition change: biomarkers
timeFrame: 4 months
measure: functional parameter related to malnutrition change: biomarkers
timeFrame: 4 months
measure: functional parameter related to malnutrition change: immunological indices
timeFrame: 4 months
measure: functional parameter related to malnutrition change: Nutritional status evaluation
timeFrame: 4 months
measure: functional parameter related to malnutrition change: Nutritional status evaluation - MNA score
timeFrame: 4 months
measure: functional parameter related to malnutrition change: Bolus transit time evaluation
timeFrame: 4 months
Locations:
city: Genova
country: Italy
facility: ASL 3 Genovese Struttura Complessa Recupero e Rieducazione Funzionale Ospedale "La Colletta" Via del Giappone, 5 - Arenzano (GE)
Study officials:
affiliation: Asl 3 genovese
name: Marina Simonini, Dr
role: PRINCIPAL_INVESTIGATOR
References: