Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
Primary Purpose
Oropharyngeal Dysphagia
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Modified consistency and volume diet
Sponsored by
About this trial
This is an interventional treatment trial for Oropharyngeal Dysphagia focused on measuring Nutritional Intervention in Oropharyngeal Dysphagia
Eligibility Criteria
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.
Sites / Locations
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Modified consistency and volume diet
Control Group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Adequacy of Oral Intake of Energy
The energy intake measured in kcal/kg/d
Adequacy of Oral Intake of Protein
The protein intake measured in protein g/kg/d
Secondary Outcome Measures
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
Mortality
number of deaths at 12 months of follow-up
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)
BMI
Body mass index at the end of study
Full Information
NCT ID
NCT02959450
First Posted
November 7, 2016
Last Updated
June 7, 2023
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT02959450
Brief Title
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
Official Title
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
July 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia
Keywords
Nutritional Intervention in Oropharyngeal Dysphagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified consistency and volume diet
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified consistency and volume diet
Intervention Description
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 Outcome Measure Information:
Title
Adequacy of Oral Intake of Energy
Description
The energy intake measured in kcal/kg/d
Time Frame
12 months
Title
Adequacy of Oral Intake of Protein
Description
The protein intake measured in protein g/kg/d
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Body Weight
Description
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
Title
Mortality
Description
number of deaths at 12 months of follow-up
Time Frame
12 months
Title
Swallowing Ability
Description
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
Title
BMI
Description
Body mass index at the end of study
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurora E Serralde-Zúñiga, MD, PhD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Ciudad de Mexico
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
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