Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia

Study Overview
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Brief Summary
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The purpose of this trial is to design, implement and evaluate the effect of a nutritional intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of energy and protein.

Detailed Description
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Oropharyngeal Dysphagia causes complications that compromise the efficacy and security of deglutition. An inefficacy deglutition increases the risk of malnutrition and/or dehydration. On the other hand, unsafe deglutition requires more time to complete the oral preparation of the bolus, which can leave residues in the mouth that can then lead to penetration of small food particles into the respiratory tract. These tracheobronchial aspirations cause aspiration pneumonia in 50% of cases, with 50% of mortality rate. Despite the enormous impact of Oropharyngeal Dysphagia in functional capacity and quality of life, this problem is underestimated and underdiagnosed as a major cause of nutritional and pulmonary complications that generate more material and human resources. There are few studies evaluating the effect of a nutritional intervention on recovery in swallowing ability or improvement of nutritional status. The purpose of this trial is to design a nutritional intervention with modified texture foods to increase viscosity (measured accurately) according to the patient's requirements, also assess if the intervention has a positive effect on the swallowing ability, calorie and protein oral intake and nutritional status.

Official Title
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Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind

Conditions
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Oropharyngeal Dysphagia

Intervention / Treatment
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* Dietary Supplement: Modified consistency and volume diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Oropharyngeal Dysphagia. Patients who have primary caregiver. Agreeing to participate in the study. Exclusion Criteria: Critically ill patients. Chronic kidney disease with Glomerular Filtration Rate <30 ml / min or in renal replacement therapy Liver failure. Cancer with active radiotherapy or chemotherapy treatment. Patients who are participating in another study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified consistency and volume diet<br>Modified consistency diet, with a certain viscosity and controlled volume. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. | Dietary Supplement: Modified consistency and volume diet<br>* Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.<br>|
| No Intervention: Control Group<br>Standard treatment consisting of a modified consistency diet with adequate intake of energy and protein and general recommendations on diet prescribed by the treating physician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of Oral Intake of Energy | The energy intake measured in kcal/kg/d | 12 months | 
| Adequacy of Oral Intake of Protein | The protein intake measured in protein g/kg/d | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | The total of kg of body weight in the intervention group in contrast with the control group at 12 months of follow-up | 12 months | 
| Mortality | number of deaths at 12 months of follow-up | 12 months | 
| Swallowing Ability | Patient's swallowing ability evaluated by volume-viscosity test, if patient is able to swallow correctly the three types of consistencies (liquid, nectar and pudding) | 12 months | 
| BMI | Body mass index at the end of study | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional Intervention in Oropharyngeal Dysphagia