Oropharyngeal Dysphagia
Conditions
Keywords
Nutritional Intervention in Oropharyngeal Dysphagia
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.
Interventions
DIETARY_SUPPLEMENTModified 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.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of Oral Intake of Energy | 12 months | The energy intake measured in kcal/kg/d |
| Adequacy of Oral Intake of Protein | 12 months | The protein intake measured in protein g/kg/d |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 12 months | The total of kg of body weight in the intervention group in contrast with the control group at 12 months of follow-up |
| Mortality | 12 months | number of deaths at 12 months of follow-up |
| Swallowing Ability | 12 months | 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 | 12 months | Body mass index at the end of study |
Countries
Mexico
Participant flow
Pre-assignment details
Patients who not agreed to participate or with severe oropharyngeal dysphagia (enteral feeding) was excluded
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| 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 | 51 |
| Total | 105 |
Baseline characteristics
| Characteristic | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 10 | 71 years STANDARD_DEVIATION 11 | 73 years STANDARD_DEVIATION 11 |
| BMI | 21 kg/m^2 STANDARD_DEVIATION 3.9 | 22 kg/m^2 STANDARD_DEVIATION 5 | 21 kg/m^2 STANDARD_DEVIATION 4.5 |
| Body weight | 56 kg STANDARD_DEVIATION 12 | 56 kg STANDARD_DEVIATION 14 | 56 kg STANDARD_DEVIATION 14 |
| Energy intake | 27 kcal/kg/d STANDARD_DEVIATION 11 | 27 kcal/kg/d STANDARD_DEVIATION 10 | 27 kcal/kg/d STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants | 51 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Handgrip strength | 15 kg STANDARD_DEVIATION 9 | 14 kg STANDARD_DEVIATION 10 | 15 kg STANDARD_DEVIATION 9 |
| Phase Angle (bioelectrical impedance) | 4.4 degrees STANDARD_DEVIATION 1.3 | 4.6 degrees STANDARD_DEVIATION 1.4 | 4.5 degrees STANDARD_DEVIATION 1.3 |
| Protein intake | 1.3 g/kg/d STANDARD_DEVIATION 0.6 | 1.2 g/kg/d STANDARD_DEVIATION 0.5 | 1.3 g/kg/d STANDARD_DEVIATION 0.6 |
| Region of Enrollment Mexico | 54 participants | 51 participants | 105 participants |
| Sex: Female, Male Female | 29 Participants | 24 Participants | 53 Participants |
| Sex: Female, Male Male | 25 Participants | 27 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 54 | 18 / 51 |
| other Total, other adverse events | 0 / 54 | 0 / 51 |
| serious Total, serious adverse events | 0 / 54 | 0 / 51 |
Outcome results
Primary
Adequacy of Oral Intake of Energy
The energy intake measured in kcal/kg/d
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Consistency and Volume Diet | Adequacy of Oral Intake of Energy | 41 kcal/kg/d | Standard Deviation 15 |
| Control Group | Adequacy of Oral Intake of Energy | 36 kcal/kg/d | Standard Deviation 12 |
Primary
Adequacy of Oral Intake of Protein
The protein intake measured in protein g/kg/d
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Consistency and Volume Diet | Adequacy of Oral Intake of Protein | 1.9 g/kg/d | Standard Deviation 0.68 |
| Control Group | Adequacy of Oral Intake of Protein | 1.5 g/kg/d | Standard Deviation 0.63 |
Secondary
BMI
Body mass index at the end of study
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Consistency and Volume Diet | BMI | 24 kg/m^2 | Standard Deviation 4 |
| Control Group | BMI | 23 kg/m^2 | Standard Deviation 6 |
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Consistency and Volume Diet | Body Weight | 62 kg | Standard Deviation 12 |
| Control Group | Body Weight | 57 kg | Standard Deviation 15 |
Secondary
Mortality
number of deaths at 12 months of follow-up
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Modified Consistency and Volume Diet | Mortality | 8 Participants |
| Control Group | Mortality | 18 Participants |
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)
Time frame: 12 months
Population: According to volume-viscosity test, number of patients that recovery the swallowing ability to eat safe
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Consistency and Volume Diet | Swallowing Ability | 26 count of patients |
| Control Group | Swallowing Ability | 22 count of patients |