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Completed

NCT Number: NCT02959450

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

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified consistency and volume diet

Dietary Supplement

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.

Primary outcomes

  1. Adequacy of Oral Intake of Energy

    Time frame: 12 months

    The energy intake measured in kcal/kg/d

  2. Adequacy of Oral Intake of Protein

    Time frame: 12 months

    The protein intake measured in protein g/kg/d

Secondary outcomes

  1. Body Weight

    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

  2. Mortality

    Time frame: 12 months

    number of deaths at 12 months of follow-up

  3. Swallowing Ability

    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)

  4. BMI

    Time frame: 12 months

    Body mass index at the end of study

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2016
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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