An interventional study of Modified consistency and volume diet in Oropharyngeal Dysphagia, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Completed at 1 site in Mexico. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-06-09.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Not applicable, Interventional, and Treatment
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 127 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 141 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: Modified consistency and volume diet
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
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.
Adequacy of Oral Intake of Energy
The energy intake measured in kcal/kg/d
Time frame: 12 months
Adequacy of Oral Intake of Protein
The protein intake measured in protein g/kg/d
Time frame: 12 months
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
Mortality
number of deaths at 12 months of follow-up
Time frame: 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)
Time frame: 12 months
BMI
Body mass index at the end of study
Time frame: 12 months
| Milestone | Modified Consistency and Volume Diet | Control Group |
|---|---|---|
| Started | 64 | 63 |
| Completed | 54 | 51 |
| Not completed | 10 | 12 |
The energy intake measured in kcal/kg/d
| kcal/kg/d | Modified Consistency and Volume Diet | Control Group |
|---|---|---|
| Adequacy of Oral Intake of Energy | 41 ± 15 | 36 ± 12 |
The protein intake measured in protein g/kg/d
| g/kg/d | Modified Consistency and Volume Diet | Control Group |
|---|---|---|
| Adequacy of Oral Intake of Protein | 1.9 ± 0.68 | 1.5 ± 0.63 |
The total of kg of body weight in the intervention group in contrast with the control group at 12 months of follow-up
| kg | Modified Consistency and Volume Diet | Control Group |
|---|---|---|
| Body Weight | 62 ± 12 | 57 ± 15 |
number of deaths at 12 months of follow-up
| Participants | Modified Consistency and Volume Diet | Control Group |
|---|---|---|
| Mortality | 8 | 18 |
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)
| count of patients | Modified Consistency and Volume Diet | Control Group |
|---|---|---|
| Swallowing Ability | 26 | 22 |
Body mass index at the end of study
| kg/m^2 | Modified Consistency and Volume Diet | Control Group |
|---|---|---|
| BMI | 24 ± 4.0 | 23 ± 6.0 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Modified Consistency and Volume Diet | 8/54 (14.8%) | 0/54 (0%) | 0/54 (0%) |
| Control Group | 18/51 (35.3%) | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(years) | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Mean | 73 ± 10 | 71 ± 11 | 73 ± 11 |
| Sex: Female, Male(Participants) | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Female | 29 | 24 | 53 |
| Male | 25 | 27 | 52 |
| Ethnicity (NIH/OMB)(Participants) | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 54 | 51 | 105 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Mexico | 54 | 51 | 105 |
| Phase Angle (bioelectrical impedance)(degrees) | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Mean | 4.4 ± 1.3 | 4.6 ± 1.4 | 4.5 ± 1.3 |
| Handgrip strength(kg) | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Mean | 15 ± 9 | 14 ± 10 | 15 ± 9 |
| Energy intake(kcal/kg/d) | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Mean | 27 ± 11 | 27 ± 10 | 27 ± 10 |
| Protein intake(g/kg/d) | Modified Consistency and Volume Diet | Control Group | Total |
|---|---|---|---|
| Mean | 1.3 ± 0.6 | 1.2 ± 0.5 | 1.3 ± 0.6 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran