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Swallowing and Nutritional Treatment on OD Patients (OD)

Primary Purpose

Oropharyngeal Dysphagia

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Personalized diet
Control
Sponsored by
Hospital General de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oropharyngeal Dysphagia focused on measuring oropharyngeal, dysphagia, nutrition

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both sexes
  • 18 to 75 years old
  • Diagnosis of dysphagia
  • Full phonological assessment
  • Any federative entity in the country

Exclusion Criteria:

  • Patients with any nephropathy
  • HIV diagnosis
  • Thyroid dysfunction dignosis
  • Gastrostomy feeded patients
  • Patients on chemotherapy
  • Psychogenic Dysphagia

Sites / Locations

  • Nallely Bueno Hernandez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized diet

Control

Arm Description

Personalized diet during the swallowing rehabilitation

Nutritional recommendations during the swallowing rehabilitation

Outcomes

Primary Outcome Measures

Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients
Changes from baseline anthropometric, biochemical, and body composition values, at 12 weeks of nutritional intervention in OD patients

Secondary Outcome Measures

Swallowing capacity
Changes from baseline of the presence or absence of food remains in the larynx and aspiration during the Fibroendoscopic Evaluation of Swallowing at 12 weeks of nutritional intervention in OD patients
Body composition analysis
Changes from baseline of the percentage of body fat, muscle and water at 12 weeks of nutritional intervention, using RJL System IV
Quality of life
Changes from baseline of WHOQOL- BREF questionary score (the higher score, the higher quality of life represents) at 12 weeks of nutritional intervention in OD patients
Anthropometric measurements
Changes from baseline of arm, waist and hips circumferences in centimeters at 12 weeks of nutritional intervention in OD patients
Nutritional Risk
Changes from baseline of malnutrition risk during the Malnutrition Universal Screening Tool score (0 = low risk; 1= medium risk 2= high risk) at 12 weeks of nutritional intervention in OD patients.
Gastrointestinal symptoms
Changes from baseline in the presence or absence of gastrointestinal symptoms according to the ROME III criteria at 12 weeks of nutritional intervention in OD patients
Dietary intake
Changes from baseline of grams of macronutrients (carbohydrates, lipids and protein) consumed, according to the 24 hours record at 12 weeks of nutritional intervention in OD patients
Blood quemistry
Changes from baseline glucose, creatinine, high density lipoproteins, low density lipoproteins, cholesterol levels (mg/dL) at 12 weeks of nutritional intervention in OD patients
Blood chemistry
Changes from baseline calcium, albumin, hemoglobin levels (g/dL) and iron (ug/dL) levels at 12 weeks of nutritional intervention in OD patients
Electrolytes blood levels
Changes from baseline sodium and potasium levels (meq/L) at 12 weeks of nutritional intervention in OD patients

Full Information

First Posted
October 8, 2019
Last Updated
October 16, 2019
Sponsor
Hospital General de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04132271
Brief Title
Swallowing and Nutritional Treatment on OD Patients
Acronym
OD
Official Title
Effect of Swallowing Rehabilitation Complemented With Nutritional Treatment on the Nutritional Status of Oropharyngeal Dysphagia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2019 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dysphagia is a difficulty during the swallowing process (transportation food from the mouth to the stomach. Oropharyngeal Dysphagia (OD) is diagnosed by videofluoroscopy and faringolaringoscopy. OD threatens the efficacy and safety of swallowing, contributing to an increased risk of aspiration and pneumonia. There are different interventions aimed to change and improve the physiology of swallowing; however, OD can be an important predictor of the progression of malnutrition in different types of patients. Malnutrition is defined as an acute or chronic disease whereby an energy imbalance, lack of energy, protein or other nutrients causes measurable and adverse effects on body composition, functional and clinical outcomes. In addition, it leads to a decrease in the quality of life. Objective: To establish a strategy of nutritional treatment and swallowing rehabilitation in patients with dysphagia. Hypothesis: An adequate nutritional intervention in content and consistency, combined with swallowing rehabilitation in patients with dysphagia, will improve the nutritional status and clinical evolution of patients with dysphagia.
Detailed Description
Introduction: Dysphagia is a difficulty during the swallowing process (transportation food from the mouth to the stomach. Oropharyngeal Dysphagia (OD) is diagnosed by videoflouroscopy and faringolaringoscopy and it is frequently associated with neurodegenerative problems. OD threatens the efficacy and safety of swallowing, contributing to an increased risk of aspiration and pneumonia. Problem statement: There are different interventions aimed to change and improve the physiology of swallowing; however, OD can be an important predictor of the progression of malnutrition in different types of patients. Malnutrition is defined as an acute or chronic disease whereby an energy imbalance, lack of energy, protein or other nutrients causes measurable and adverse effects on body composition, functional and clinical outcomes. In addition, it leads to a decrease in the quality of life. Justification: It is essential to provide adequate nutritional interventions according to the specifications of the dysphagia in order to improve the nutritional status of these patients, as well to provide adequate early nutritional treatment when changing from tube to oral feeding, focusing on dietary factors that can significantly improve nutrition of the patient. However, there are no studies that evaluate the specific requirements for the nutritional treatment of these patients. By implementing a diet based on improving the safety and efficacy of swallowing in patients with OD, specific nutritional recommendations that impact on the rate of malnutrition and mortality of the different pathologies that present this condition could be established. Objective: To establish a strategy of nutritional treatment and swallowing rehabilitation in patients with dysphagia. Hypothesis: An adequate nutritional intervention in content and consistency, combined with swallowing rehabilitation in patients with dysphagia, will improve the nutritional status and clinical evolution of patients with dysphagia. Methodology: This is a prospective randomized controlled clinical trial, in which OD patients will be recruited to participate. The participants will be receiving swallowing rehabilitation by a specialist phoniatrician. They will be randomise assigned to a special nutritional treatment during 12 weeks. Swallowing rehabilitation, laboratory analyses, anthropometric measurements and consume and quality of life questionaries will be carried out.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Dysphagia
Keywords
oropharyngeal, dysphagia, nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized diet
Arm Type
Experimental
Arm Description
Personalized diet during the swallowing rehabilitation
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Nutritional recommendations during the swallowing rehabilitation
Intervention Type
Other
Intervention Name(s)
Personalized diet
Intervention Description
Modified texture and volumen diet according to the OD specifications
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Nutritional Recommendations
Intervention Description
Nutritional Recommendations according to the OD specifications
Primary Outcome Measure Information:
Title
Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients
Description
Changes from baseline anthropometric, biochemical, and body composition values, at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1, 6 and 12
Secondary Outcome Measure Information:
Title
Swallowing capacity
Description
Changes from baseline of the presence or absence of food remains in the larynx and aspiration during the Fibroendoscopic Evaluation of Swallowing at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1, 6 and 12
Title
Body composition analysis
Description
Changes from baseline of the percentage of body fat, muscle and water at 12 weeks of nutritional intervention, using RJL System IV
Time Frame
Participants will be evaluated at weeks 1, 6 and 12
Title
Quality of life
Description
Changes from baseline of WHOQOL- BREF questionary score (the higher score, the higher quality of life represents) at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1, 6 and 12
Title
Anthropometric measurements
Description
Changes from baseline of arm, waist and hips circumferences in centimeters at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1, 6 and 12
Title
Nutritional Risk
Description
Changes from baseline of malnutrition risk during the Malnutrition Universal Screening Tool score (0 = low risk; 1= medium risk 2= high risk) at 12 weeks of nutritional intervention in OD patients.
Time Frame
Participants will be evaluated at weeks 1, 6 and 12
Title
Gastrointestinal symptoms
Description
Changes from baseline in the presence or absence of gastrointestinal symptoms according to the ROME III criteria at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1, 6 and 12
Title
Dietary intake
Description
Changes from baseline of grams of macronutrients (carbohydrates, lipids and protein) consumed, according to the 24 hours record at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1, 6 and 12
Title
Blood quemistry
Description
Changes from baseline glucose, creatinine, high density lipoproteins, low density lipoproteins, cholesterol levels (mg/dL) at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1 and 12
Title
Blood chemistry
Description
Changes from baseline calcium, albumin, hemoglobin levels (g/dL) and iron (ug/dL) levels at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1 and 12
Title
Electrolytes blood levels
Description
Changes from baseline sodium and potasium levels (meq/L) at 12 weeks of nutritional intervention in OD patients
Time Frame
Participants will be evaluated at weeks 1 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both sexes 18 to 75 years old Diagnosis of dysphagia Full phonological assessment Any federative entity in the country Exclusion Criteria: Patients with any nephropathy HIV diagnosis Thyroid dysfunction dignosis Gastrostomy feeded patients Patients on chemotherapy Psychogenic Dysphagia
Facility Information:
Facility Name
Nallely Bueno Hernandez
City
Mexico City
State/Province
Cuauhtemoc
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

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Swallowing and Nutritional Treatment on OD Patients

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