Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia. Compared With Traditional Practice: Randomized Clinical Trial, Simple Blind
Phase: NA
Conditions: Oropharyngeal Dysphagia
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

 
 
 
 
 
 
 
 
 
 
 
Design and Implementation of a Nutritional Intervention in 
Patients With Oropharyngeal Dysphagia 
NCT02959450 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
October 10th, 2021 

Patients of 18 years and older, both genders, who had a primary caregiver and a 
confirmed diagnosis of OD were included. Eating Assessment Tool (EAT-10) and 
Volume- Viscosity Swallow Test (V-VST) were performed by a clinical nutritionist in 
order to evaluate the safety and efficacy of swallowing and confirm the diagnosis of 
OD; select the type of viscosity and volume appropriate for the prescription of the 
texture-modified diet. Patients with cancer, kidney or hepatic failure, terminally ill 
patients, as were as high risk of aspiration, reporting a decrease in oxygen saturation 
>5% in the V-VST, or with enteral nutrition (EN) through a nasoenteral tube or 
gastrostomy were excluded. We estimated a sample size of 50 patients per group 
by the formula of survival of Argimon et al , with an alpha level of 0.05 and more than 
90% power to detect a difference of 15% of mortality between groups. 
 
Anthropometry 
Anthropometric measurements were performed according to the reference manual 
for anthropometric standarization. The same scale was used for all patients at each 
visit. Forearm circumference was measured at the midpoint of the right arm and calf 
circumference was measured in a supine position with the tape along the calf to 
measure the greatest circumference without compressing the subcutaneous tissue. 
 
Mini Nutritional Assessment 
The nutritional risk was assessed using the Mini Nutritional Assessment (MNA) 
questionnaire, a valid and realiable tool to identify malnutrition in elderly people. 
The original version of this tool was used for this study contained 18 questions with 
a maximum of 30 points. It is considered that a score lower than 17 points 
represents malnutrition, between 17 and 23.5 points of risk of malnutrition and more 
than 24 points that the patient iswell nourished. 
 
Dietary intake 
For the evaluation of the quality and quantity of dietary intake, a 24-hour multiple- 
step recall was aplied and the Food Processor Nutrition Analysis® software was 
used for the detailed nutritional analysis. 

 
Body composition 
The body composition was performed using a single-frecuency BIA (50-kHz, 
Quantum X, RJL Systems, Inc) with the standard technique: all participants were 
supine with limbs slightly spread apart from the body, refrained from eating, 
drinking, and exercising for six hours, no alcohol within 24 h before testing and 
portable electric heaters. The area was cleaned with alcohol and the electrodes 
(recommended by manufacturers RJL Systems, Inc) were placed on an imaginary 
line bisecting the ulner head of the right hand and on an imaginary line bisecting 
the medial malleolus of the right finger and on the base of the second toe of the right 
foot. Finally, the R and Xc values were recorded. All measurements were 
performed under strictly standardized conditions by the observer, using the same 
device in order to avoid interobserver and interdevice variability. The Quantum X 
was calibrated periodically by a test resistor with a known value of 495 – 505 ohms 
of R to ensure accuracy of measurements. The coefficient of variation was reported 
in a range from 1.8 to 2.9%. 
 
Muscle strength 
The muscular functionality was evaluated by a handgrip dynamometer (Takei®). 
The operator, using the same device in order to avoid interobserver and inter 
device variability, performed all measurements under strictly standardized 
conditions. For the measurement, subjects were placed standing with arms 
outstretched parallel to the trunk taking the dynamometer and applying maximum 
strength with each hand without support. The measurement was repeated three 
times with separation of 1 min to avoid fatigue and the maximum value was 
recorded. The instrument was routinely checked resistors and capacitors of known 
values. 
 
Nutritional intervention 
Nutritional requirements for both groups were calculated based on the American 
Society for Parenteral and Enteral Nutrition and Society of Critical Care Medicine 
(A.S.P.E.N./S.C.C.M.) and recommendations of PROT-AGE Study Group as follows: 
25- 30 kcal/kg Body Weight (BW)/day in patients with body mass index (BMI) <30 
kg/m2 and 20-25 kcal/kg ideal BW/day with BMI> 30 kg/m2; protein were 

calculated 1.2-1.5 g/kg 

BW/day for patients with BMI <30 km/m2 and in case that BMI was >30 kg/m2 
protein were calculated 2 g/kg ideal BW/day in both groups. Both groups received 
swallowing 
rehabilitation 
(postural 
maneuvers, 
increase 
oral 
sensitivity, 
neuromuscular practices). 
 
Subjects were randomly allocated to intervention group (modified consistency diet, 
with a nectar or pudding viscosity) or control group (standard treatment) using a 
blocked allocation strategy. The control group received a traditional modified texture 
diet, with pureed foods and one viscosity of thickened drinks. The viscosity 
beverages were not systematically controlled. For the intervention group a chef and 
a clinical nutritionist developed the texture- modified foods and thickened drinks 
diet, with nectar or pudding viscosity and controlled bolus volume. The foods were 
thickened using Enterex Food Thickener, Victus® and the viscosity of menus was 
standardized and measured with a Brookfield Viscometer (model RV). The menus 
with nectar consistency had a viscosity of 51-350 centipoises (cP) and the pudding 
consistency foods with a higher viscosity at 1,750 cP. The viscosity of the diet was 
prescribed according to the viscosity and volume tolerated in the V-VST. A recipe 
book for caregivers and patients was made to facilitate the preparation of the diet 
with the exact amount of thickener to use in each menu to achieve the desired 
viscosity. Training was also provided to patients and caregivers by a video on the 
use of food thickener (modified ediblestarch) on each menu. 
 
The primary outcome was the amount of energy (kcal/kg) and protein (g/kg) 
consumed, the secondary outcome was body composition and muscular 
functionality. The follow-up was carried out in 5 visits during 12 weeks. Adherence 
to the prescribed meal plan was evaluated at each visit. To evaluate the adherence, 
it was necessary to have an intake of more than 80% of the nutritional requirements 
with 24-hour recall. If the intake was lower than indicated, oral nutritional 
supplements were prescribed to meet the nutritional requirements established in 
both groups.