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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of Oral Intake of Energy | The energy intake measured in kcal/kg/d | 12 months |
| Adequacy of Oral Intake of Protein | The protein intake measured in protein g/kg/d | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Mortality | number of deaths at 12 months of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurora E Serralde-Zúñiga, MD, PhD | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15919036 | Result | 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. | |
| 24262954 | Result | Roden 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. |
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Patients who not agreed to participate or with severe oropharyngeal dysphagia (enteral feeding) was excluded
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Consistency and Volume Diet | 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. Modified consistency and volume diet: 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. |
| FG001 | Control Group | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Consistency and Volume Diet | 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. Modified consistency and volume diet: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adequacy of Oral Intake of Energy | The energy intake measured in kcal/kg/d | Posted | Mean | Standard Deviation | kcal/kg/d | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Consistency and Volume Diet | 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. Modified consistency and volume diet: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aurora Serralde | INCMNSZ | +52-55-54870900 | 2193 | aurora.serraldez@incmnsz.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2021 | Oct 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2021 | Oct 11, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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|
| 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) | 12 months |
| BMI | Body mass index at the end of study | 12 months |
| 15255021 | Result | Clave 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. |
| 18789561 | Result | Clave 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. |
| 10734019 | Result | Wallace 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. |
| 19140539 | Result | Belafsky 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. |
| 23588456 | Result | Burgos 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. |
| 11523474 | Result | Aviv 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. |
| 24882372 | Result | Carrion 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. |
| 14609974 | Result | Finestone 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. |
| 18239168 | Result | Jonsson 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. |
| 17315085 | Result | Brynningsen 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. |
| 11956839 | Result | Ekberg 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. |
| 20392703 | Result | Cruz-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. |
| 25223471 | Result | Wakabayashi 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. |
| 22985156 | Result | Kuroda Y, Kuroda R. Relationship between thinness and swallowing function in Japanese older adults: implications for sarcopenic dysphagia. J Am Geriatr Soc. 2012 Sep;60(9):1785-6. doi: 10.1111/j.1532-5415.2012.04123.x. No abstract available. |
| 17927938 | Result | Almirall J, Cabre M, Clave P. [Aspiration pneumonia]. Med Clin (Barc). 2007 Sep 29;129(11):424-32. doi: 10.1157/13110467. Spanish. |
| 17000194 | Result | Germain I, Dufresne T, Gray-Donald K. A novel dysphagia diet improves the nutrient intake of institutionalized elders. J Am Diet Assoc. 2006 Oct;106(10):1614-23. doi: 10.1016/j.jada.2006.07.008. |
| 16735082 | Result | Volkert D, Berner YN, Berry E, Cederholm T, Coti Bertrand P, Milne A, Palmblad J, Schneider S, Sobotka L, Stanga Z; DGEM (German Society for Nutritional Medicine); Lenzen-Grossimlinghaus R, Krys U, Pirlich M, Herbst B, Schutz T, Schroer W, Weinrebe W, Ockenga J, Lochs H; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Geriatrics. Clin Nutr. 2006 Apr;25(2):330-60. doi: 10.1016/j.clnu.2006.01.012. |
| 12834525 | Result | Loeb MB, Becker M, Eady A, Walker-Dilks C. Interventions to prevent aspiration pneumonia in older adults: a systematic review. J Am Geriatr Soc. 2003 Jul;51(7):1018-22. doi: 10.1046/j.1365-2389.2003.51318.x. |
| 19064135 | Result | Wieseke A, Bantz D, Siktberg L, Dillard N. Assessment and early diagnosis of dysphagia. Geriatr Nurs. 2008 Nov-Dec;29(6):376-83. doi: 10.1016/j.gerinurse.2007.12.001. |
| 19699405 | Result | Cook IJ. Oropharyngeal dysphagia. Gastroenterol Clin North Am. 2009 Sep;38(3):411-31. doi: 10.1016/j.gtc.2009.06.003. |
| 18674990 | Result | Hansen TS, Engberg AW, Larsen K. Functional oral intake and time to reach unrestricted dieting for patients with traumatic brain injury. Arch Phys Med Rehabil. 2008 Aug;89(8):1556-62. doi: 10.1016/j.apmr.2007.11.063. |
| 24177285 | Result | Malone A, Hamilton C. The Academy of Nutrition and Dietetics/the American Society for Parenteral and Enteral Nutrition consensus malnutrition characteristics: application in practice. Nutr Clin Pract. 2013 Dec;28(6):639-50. doi: 10.1177/0884533613508435. Epub 2013 Oct 31. |
| 25850008 | Result | Clave P, Shaker R. Dysphagia: current reality and scope of the problem. Nat Rev Gastroenterol Hepatol. 2015 May;12(5):259-70. doi: 10.1038/nrgastro.2015.49. Epub 2015 Apr 7. |
| BG001 | Control Group | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Phase Angle (bioelectrical impedance) | This measurement was taken with a multifrequency bioelectrical impedance analyser (Inbody S10). The outcome is the result from the arctg X (resistance)/R (reactance) | Mean | Standard Deviation | degrees |
|
| Handgrip strength | Mean | Standard Deviation | kg |
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| Energy intake | Mean | Standard Deviation | kcal/kg/d |
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| Protein intake | Mean | Standard Deviation | g/kg/d |
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| Body weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Control Group | 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 |
|
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| Primary | Adequacy of Oral Intake of Protein | The protein intake measured in protein g/kg/d | Posted | Mean | Standard Deviation | g/kg/d | 12 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | kg | 12 months |
|
|
|
| Secondary | Mortality | number of deaths at 12 months of follow-up | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | 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) | According to volume-viscosity test, number of patients that recovery the swallowing ability to eat safe | Posted | Number | count of patients | 12 months |
|
|
|
| Secondary | BMI | Body mass index at the end of study | Posted | Mean | Standard Deviation | kg/m^2 | 12 months |
|
|
|
| 8 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Control Group | 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 | 18 | 51 | 0 | 51 | 0 | 51 |
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| D010038 | Otorhinolaryngologic Diseases |