Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080, Mexico
NCT Number: NCT02959450
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.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Mexico City, 14080, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 months
The energy intake measured in kcal/kg/d
Time frame: 12 months
The protein intake measured in protein g/kg/d
Time frame: 12 months
The total of kg of body weight in the intervention group in contrast with the control group at 12 months of follow-up
Time frame: 12 months
number of deaths at 12 months of follow-up
Time frame: 12 months
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)
Time frame: 12 months
Body mass index at the end of study
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Other
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind
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