Oropharyngeal DysphagiaODNCT04132271
Swallowing and Nutritional Treatment on OD Patients
A study testing Personalized diet in people with Oropharyngeal Dysphagia, run by Hospital General de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- Personalized diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMexico
- Study dates
- 3 Dec 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes
- 18 to 75 years old
- Diagnosis of dysphagia
- Full phonological assessment
- Any federative entity in the country
Who cannot join
- Patients with any nephropathy
- HIV diagnosis
- Thyroid dysfunction dignosis
- Gastrostomy feeded patients
- Patients on chemotherapy
- Psychogenic Dysphagia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Swallowing Rehabilitation Complemented With Nutritional Treatment on the Nutritional Status of Oropharyngeal Dysphagia Patients
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.
Read the 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.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- Personalized diet, Control
- Keywords
- oropharyngeal, dysphagia, nutrition
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized dietOther
Modified texture and volumen diet according to the OD specifications
ControlOther
Also called Nutritional Recommendations
Nutritional Recommendations according to the OD specifications
| Study group | Role | What they receive |
|---|---|---|
| Personalized diet | Experimental | Personalized diet during the swallowing rehabilitation Receives: Other: Personalized diet |
| Control | Active comparator | Nutritional recommendations during the swallowing rehabilitation Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants will be evaluated at weeks 1, 6 and 12
Secondary outcomes (10)
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
Measured: Participants will be evaluated at weeks 1, 6 and 12
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
Measured: Participants will be evaluated at weeks 1, 6 and 12
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
Measured: Participants will be evaluated at weeks 1, 6 and 12
Anthropometric measurements
Changes from baseline of arm, waist and hips circumferences in centimeters at 12 weeks of nutritional intervention in OD patients
Measured: Participants will be evaluated at weeks 1, 6 and 12
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.
Measured: Participants will be evaluated at weeks 1, 6 and 12
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
Measured: Participants will be evaluated at weeks 1, 6 and 12
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
Measured: Participants will be evaluated at weeks 1, 6 and 12
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
Measured: Participants will be evaluated at weeks 1 and 12
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
Measured: Participants will be evaluated at weeks 1 and 12
Electrolytes blood levels
Changes from baseline sodium and potasium levels (meq/L) at 12 weeks of nutritional intervention in OD patients
Measured: Participants will be evaluated at weeks 1 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start3 Dec 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nallely Bueno Hernández, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132271
- Sponsor's protocol ID
- DI/19/301/03/003
- Acronym
- OD
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Swallowing Rehabilitation Complemented With Nutritional Treatment on the Nutritional Status of Oropharyngeal Dysphagia Patients
- ClinicalTrials.gov ID
- NCT04132271
- Acronym / sponsor ID
- OD / DI/19/301/03/003
- Conditions
- Oropharyngeal Dysphagia
- Keywords
- oropharyngeal, dysphagia, nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 3 Dec 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized diet | Experimental | Other: Personalized dietPersonalized diet during the swallowing rehabilitation |
| Control | Active comparator | Other: ControlNutritional recommendations during the swallowing rehabilitation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both sexes
- 18 to 75 years old
- Diagnosis of dysphagia
- Full phonological assessment
- Any federative entity in the country
Key exclusion criteria (6 listed)
- Patients with any nephropathy
- HIV diagnosis
- Thyroid dysfunction dignosis
- Gastrostomy feeded patients
- Patients on chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized dietModified texture and volumen diet according to the OD specifications | Other | Personalized diet |
| ControlAlso: Nutritional RecommendationsNutritional Recommendations according to the OD specifications | Other | Control |
Primary outcome
Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients
Time frame: Participants will be evaluated at weeks 1, 6 and 12
Changes from baseline anthropometric, biochemical, and body composition values, at 12 weeks of nutritional intervention in OD patients
10 secondary outcomes
Swallowing capacity
Time frame: Participants will be evaluated at weeks 1, 6 and 12
Body composition analysis
Time frame: Participants will be evaluated at weeks 1, 6 and 12
Quality of life
Time frame: Participants will be evaluated at weeks 1, 6 and 12
Anthropometric measurements
Time frame: Participants will be evaluated at weeks 1, 6 and 12
Nutritional Risk
Time frame: Participants will be evaluated at weeks 1, 6 and 12
Gastrointestinal symptoms
Time frame: Participants will be evaluated at weeks 1, 6 and 12
Dietary intake
Time frame: Participants will be evaluated at weeks 1, 6 and 12
Blood quemistry
Time frame: Participants will be evaluated at weeks 1 and 12
Blood chemistry
Time frame: Participants will be evaluated at weeks 1 and 12
Electrolytes blood levels
Time frame: Participants will be evaluated at weeks 1 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized diet in people with Oropharyngeal Dysphagia, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional intervention and swallowing rehabilitation on nutritional status of OD patients (time frame: Participants will be evaluated at weeks 1, 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.