Oropharyngeal DysphagiaNCT02959450
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
A study testing Modified consistency and volume diet in people with Oropharyngeal Dysphagia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- Modified consistency and volume diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteMexico
- Study dates
- May 2015to Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Oropharyngeal Dysphagia.
- Patients who have primary caregiver.
- Agreeing to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
About this study
Official title: Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind
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.
Read the 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.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- Modified consistency and volume diet
- Keywords
- Nutritional Intervention in Oropharyngeal Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified consistency and volume dietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Modified consistency and volume diet | Experimental | 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. Receives: Dietary Supplement: Modified consistency and volume diet |
| Control Group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of Oral Intake of Energy
The energy intake measured in kcal/kg/d
Measured: 12 months
Adequacy of Oral Intake of Protein
The protein intake measured in protein g/kg/d
Measured: 12 months
Secondary outcomes (4)
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
Measured: 12 months
Mortality
number of deaths at 12 months of follow-up
Measured: 12 months
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)
Measured: 12 months
BMI
Body mass index at the end of study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startMay 2015
- Primary completionJul 2021
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurora Elizabeth Serralde Zúñiga, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aurora E Serralde-Zúñiga, MD, PhD, Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959450
- Sponsor's protocol ID
- 1557
- Status last verified
- Jun 2023
- First submitted
- 7 Nov 2016
- Last updated
- 9 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clave P, Verdaguer A, Arreola V. [Oral-pharyngeal dysphagia in the elderly]. Med Clin (Barc). 2005 May 21;124(19):742-8. doi: 10.1157/13075447. No abstract available. Spanish.
PubMed 15919036Roden DF, Altman KW. Causes of dysphagia among different age groups: a systematic review of the literature. Otolaryngol Clin North Am. 2013 Dec;46(6):965-87. doi: 10.1016/j.otc.2013.08.008. Epub 2013 Oct 12.
PubMed 24262954Clave P, Terre R, de Kraa M, Serra M. Approaching oropharyngeal dysphagia. Rev Esp Enferm Dig. 2004 Feb;96(2):119-31. doi: 10.4321/s1130-01082004000200005. No abstract available. English, Spanish.
PubMed 15255021Clave P, Arreola V, Romea M, Medina L, Palomera E, Serra-Prat M. Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal dysphagia and aspiration. Clin Nutr. 2008 Dec;27(6):806-15. doi: 10.1016/j.clnu.2008.06.011. Epub 2008 Sep 11.
PubMed 18789561Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. doi: 10.1016/s0016-5085(00)70137-5.
PubMed 10734019Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
PubMed 19140539Burgos R, Sarto B, Segurola H, Romagosa A, Puiggros C, Vazquez C, Cardenas G, Barcons N, Araujo K, Perez-Portabella C. [Translation and validation of the Spanish version of the EAT-10 (Eating Assessment Tool-10) for the screening of dysphagia]. Nutr Hosp. 2012 Nov-Dec;27(6):2048-54. doi: 10.3305/nh.2012.27.6.6100. Spanish.
PubMed 23588456Aviv JE, Sataloff RT, Cohen M, Spitzer J, Ma G, Bhayani R, Close LG. Cost-effectiveness of two types of dysphagia care in head and neck cancer: a preliminary report. Ear Nose Throat J. 2001 Aug;80(8):553-6, 558.
PubMed 11523474Carrion S, Cabre M, Monteis R, Roca M, Palomera E, Serra-Prat M, Rofes L, Clave P. Oropharyngeal dysphagia is a prevalent risk factor for malnutrition in a cohort of older patients admitted with an acute disease to a general hospital. Clin Nutr. 2015 Jun;34(3):436-42. doi: 10.1016/j.clnu.2014.04.014. Epub 2014 May 9.
PubMed 24882372Finestone HM, Greene-Finestone LS. Rehabilitation medicine: 2. Diagnosis of dysphagia and its nutritional management for stroke patients. CMAJ. 2003 Nov 11;169(10):1041-4.
PubMed 14609974Jonsson AC, Lindgren I, Norrving B, Lindgren A. Weight loss after stroke: a population-based study from the Lund Stroke Register. Stroke. 2008 Mar;39(3):918-23. doi: 10.1161/STROKEAHA.107.497602. Epub 2008 Jan 31.
PubMed 18239168Brynningsen PK, Damsgaard EM, Husted SE. Improved nutritional status in elderly patients 6 months after stroke. J Nutr Health Aging. 2007 Jan-Feb;11(1):75-9.
PubMed 17315085Ekberg O, Hamdy S, Woisard V, Wuttge-Hannig A, Ortega P. Social and psychological burden of dysphagia: its impact on diagnosis and treatment. Dysphagia. 2002 Spring;17(2):139-46. doi: 10.1007/s00455-001-0113-5.
PubMed 11956839Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Wakabayashi H, Sakuma K. Rehabilitation nutrition for sarcopenia with disability: a combination of both rehabilitation and nutrition care management. J Cachexia Sarcopenia Muscle. 2014 Dec;5(4):269-77. doi: 10.1007/s13539-014-0162-x. Epub 2014 Sep 16.
PubMed 25223471
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind
- ClinicalTrials.gov ID
- NCT02959450
- Acronym / sponsor ID
- 1557
- Conditions
- Oropharyngeal Dysphagia
- Keywords
- Nutritional Intervention in Oropharyngeal Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified consistency and volume diet | Experimental | Dietary Supplement: Modified consistency and volume dietModified 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. |
| Control Group | No intervention | –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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Oropharyngeal Dysphagia.
- Patients who have primary caregiver.
- Agreeing to participate in the study.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Modified consistency and volume dietModified 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. | Dietary supplement | Modified consistency and volume diet |
Primary outcome
Adequacy of Oral Intake of Energy
Time frame: 12 months
The energy intake measured in kcal/kg/d
Adequacy of Oral Intake of Protein
Time frame: 12 months
The protein intake measured in protein g/kg/d
4 secondary outcomes
Body Weight
Time frame: 12 months
Mortality
Time frame: 12 months
Swallowing Ability
Time frame: 12 months
BMI
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15919036Clave P, Verdaguer A, Arreola V. [Oral-pharyngeal dysphagia in the elderly]. Med Clin (Barc). 2005 May 21;124(19):742-8. doi: 10.1157/13075447. No abstract available. Spanish.
- Results publication: PubMed 24262954Roden DF, Altman KW. Causes of dysphagia among different age groups: a systematic review of the literature. Otolaryngol Clin North Am. 2013 Dec;46(6):965-87. doi: 10.1016/j.otc.2013.08.008. Epub 2013 Oct 12.
- Results publication: PubMed 15255021Clave P, Terre R, de Kraa M, Serra M. Approaching oropharyngeal dysphagia. Rev Esp Enferm Dig. 2004 Feb;96(2):119-31. doi: 10.4321/s1130-01082004000200005. No abstract available. English, Spanish.
- Results publication: PubMed 18789561Clave P, Arreola V, Romea M, Medina L, Palomera E, Serra-Prat M. Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal dysphagia and aspiration. Clin Nutr. 2008 Dec;27(6):806-15. doi: 10.1016/j.clnu.2008.06.011. Epub 2008 Sep 11.
- Results publication: PubMed 10734019Wallace KL, Middleton S, Cook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology. 2000 Apr;118(4):678-87. doi: 10.1016/s0016-5085(00)70137-5.
- Results publication: PubMed 19140539Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.
- Results publication: PubMed 23588456Burgos R, Sarto B, Segurola H, Romagosa A, Puiggros C, Vazquez C, Cardenas G, Barcons N, Araujo K, Perez-Portabella C. [Translation and validation of the Spanish version of the EAT-10 (Eating Assessment Tool-10) for the screening of dysphagia]. Nutr Hosp. 2012 Nov-Dec;27(6):2048-54. doi: 10.3305/nh.2012.27.6.6100. Spanish.
- Results publication: PubMed 11523474Aviv JE, Sataloff RT, Cohen M, Spitzer J, Ma G, Bhayani R, Close LG. Cost-effectiveness of two types of dysphagia care in head and neck cancer: a preliminary report. Ear Nose Throat J. 2001 Aug;80(8):553-6, 558.
- Results publication: PubMed 24882372Carrion S, Cabre M, Monteis R, Roca M, Palomera E, Serra-Prat M, Rofes L, Clave P. Oropharyngeal dysphagia is a prevalent risk factor for malnutrition in a cohort of older patients admitted with an acute disease to a general hospital. Clin Nutr. 2015 Jun;34(3):436-42. doi: 10.1016/j.clnu.2014.04.014. Epub 2014 May 9.
- Results publication: PubMed 14609974Finestone HM, Greene-Finestone LS. Rehabilitation medicine: 2. Diagnosis of dysphagia and its nutritional management for stroke patients. CMAJ. 2003 Nov 11;169(10):1041-4.
- Results publication: PubMed 18239168Jonsson AC, Lindgren I, Norrving B, Lindgren A. Weight loss after stroke: a population-based study from the Lund Stroke Register. Stroke. 2008 Mar;39(3):918-23. doi: 10.1161/STROKEAHA.107.497602. Epub 2008 Jan 31.
- Results publication: PubMed 17315085Brynningsen PK, Damsgaard EM, Husted SE. Improved nutritional status in elderly patients 6 months after stroke. J Nutr Health Aging. 2007 Jan-Feb;11(1):75-9.
- Individual participant dataSharing planned: No
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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.
Aurora E Serralde-Zúñiga, MD, PhD principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified consistency and volume diet in people with Oropharyngeal Dysphagia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adequacy of Oral Intake of Energy (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02959450, which also lists 25 linked publications.
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 9 Jun 2023.