Trial Outcomes & Findings for Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia (NCT NCT02959450)
NCT ID: NCT02959450
Last Updated: 2023-06-09
Results Overview
The energy intake measured in kcal/kg/d
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
127 participants
Primary outcome timeframe
12 months
Results posted on
2023-06-09
Participant Flow
Patients who not agreed to participate or with severe oropharyngeal dysphagia (enteral feeding) was excluded
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
Baseline characteristics by cohort
| Measure |
Modified Consistency and Volume Diet
n=54 Participants
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.
|
Control Group
n=51 Participants
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
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 10 • n=99 Participants
|
71 years
STANDARD_DEVIATION 11 • n=107 Participants
|
73 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
54 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
54 participants
n=99 Participants
|
51 participants
n=107 Participants
|
105 participants
n=206 Participants
|
|
Phase Angle (bioelectrical impedance)
|
4.4 degrees
STANDARD_DEVIATION 1.3 • n=99 Participants
|
4.6 degrees
STANDARD_DEVIATION 1.4 • n=107 Participants
|
4.5 degrees
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Handgrip strength
|
15 kg
STANDARD_DEVIATION 9 • n=99 Participants
|
14 kg
STANDARD_DEVIATION 10 • n=107 Participants
|
15 kg
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Energy intake
|
27 kcal/kg/d
STANDARD_DEVIATION 11 • n=99 Participants
|
27 kcal/kg/d
STANDARD_DEVIATION 10 • n=107 Participants
|
27 kcal/kg/d
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Protein intake
|
1.3 g/kg/d
STANDARD_DEVIATION 0.6 • n=99 Participants
|
1.2 g/kg/d
STANDARD_DEVIATION 0.5 • n=107 Participants
|
1.3 g/kg/d
STANDARD_DEVIATION 0.6 • n=206 Participants
|
|
Body weight
|
56 kg
STANDARD_DEVIATION 12 • n=99 Participants
|
56 kg
STANDARD_DEVIATION 14 • n=107 Participants
|
56 kg
STANDARD_DEVIATION 14 • n=206 Participants
|
|
BMI
|
21 kg/m^2
STANDARD_DEVIATION 3.9 • n=99 Participants
|
22 kg/m^2
STANDARD_DEVIATION 5.0 • n=107 Participants
|
21 kg/m^2
STANDARD_DEVIATION 4.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe energy intake measured in kcal/kg/d
Outcome measures
| Measure |
Modified Consistency and Volume Diet
n=54 Participants
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.
|
Control Group
n=51 Participants
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
|
|---|---|---|
|
Adequacy of Oral Intake of Energy
|
41 kcal/kg/d
Standard Deviation 15
|
36 kcal/kg/d
Standard Deviation 12
|
PRIMARY outcome
Timeframe: 12 monthsThe protein intake measured in protein g/kg/d
Outcome measures
| Measure |
Modified Consistency and Volume Diet
n=54 Participants
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.
|
Control Group
n=51 Participants
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
|
|---|---|---|
|
Adequacy of Oral Intake of Protein
|
1.9 g/kg/d
Standard Deviation 0.68
|
1.5 g/kg/d
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: 12 monthsThe total of kg of body weight in the intervention group in contrast with the control group at 12 months of follow-up
Outcome measures
| Measure |
Modified Consistency and Volume Diet
n=54 Participants
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.
|
Control Group
n=51 Participants
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
|
|---|---|---|
|
Body Weight
|
62 kg
Standard Deviation 12
|
57 kg
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 12 monthsnumber of deaths at 12 months of follow-up
Outcome measures
| Measure |
Modified Consistency and Volume Diet
n=54 Participants
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.
|
Control Group
n=51 Participants
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
|
|---|---|---|
|
Mortality
|
8 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: According to volume-viscosity test, number of patients that recovery the swallowing ability to eat safe
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)
Outcome measures
| Measure |
Modified Consistency and Volume Diet
n=54 Participants
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.
|
Control Group
n=51 Participants
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
|
|---|---|---|
|
Swallowing Ability
|
26 count of patients
|
22 count of patients
|
SECONDARY outcome
Timeframe: 12 monthsBody mass index at the end of study
Outcome measures
| Measure |
Modified Consistency and Volume Diet
n=54 Participants
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.
|
Control Group
n=51 Participants
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
|
|---|---|---|
|
BMI
|
24 kg/m^2
Standard Deviation 4.0
|
23 kg/m^2
Standard Deviation 6.0
|
Adverse Events
Modified Consistency and Volume Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place