Coverage of Requirements After Consumption of a Nutritional Formula in Patients With Chewing/Swallowing Problems.

Instituto de Investigación Hospital Universitario La Paz60 enrolled

Overview

Effect of a nutritional formula on the nutritional requirements in patients with chewing/swallowing problems during one month

30 patients will receive nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day (One salted packet for lunch/dinner and one sweet packet for breakfast/afternoon snack) and recommendations for physical activity for one month. 30 patients will receive nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity during one month.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Deglutition Disorders Nutritional Deficiency Chew Problems Swallowing Disorder

Interventions

Control Group (education, guidelines, recommendations)OTHER

Nutritional education and guidelines for the consumption of a completed shreded diet and recommendations for physical activity for one month.

Experimental Group (education, guidelines, 2 pckts diet, recommendations)OTHER

Nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day and recommendations for physical activity for one month.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women over 18 years old. * Individuals with chewing/swallowing disorder. * Individuals well nourished or at malnutrition risk. * Adequate cultural level and understanding of the clinical trial. * Signed informed consent. Exclusion Criteria: * Individuals with body mass index ≥40 kg/m2. * Individuals with acute, severe or chronic disease without control. * Individuals with major surgeries during the last month. * Individuals with gastrointestinal surgery the last three months. * Individuals with moderate/severe cognitive impairment. * Individuals with severe malnutrition. * Individuals with amyotrophic lateral sclerosis. * Individuals who consume nutritional oral supplements seven days prior to the start of the study. * Enteral or parenteral nutrition.

Locations (1)

Institute for Health Research IdiPAZ

Madrid, Spain

Outcomes

Primary Outcomes

Percentage of nutritional changes with regard to the nutritional requirements recommended

Change percentage = (energy consumption at the end of the intervention period - energy consumption at the beginning of the intervention period) / energy consumption at the beginning of the intervention period \* 100

Time frame: Up to one month

Secondary Outcomes

Change from Baseline Anthropometric Parameters

Weight and Height to calcule BMI in kg/m2

Time frame: Up to one month

Change from Baseline Anthropometric Parameters

Waist Circumference

Time frame: Up to one month

24h Dietary Recall Questionnaire

Food and activity habits of people

Time frame: Up to one month

Adverse Effects

Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)

Time frame: Up to one month

Sensory perception

Sensory Perception Scale

Time frame: Up to one month

Functionality Variables

Force dynamometry hand

Time frame: Up to one month

Tolerance and adverse effects

Tolerance and adverse effects questionnaire

Time frame: Up to one month

Data from ClinicalTrials.gov

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