Clinical trial NCT03727191: Coverage of Requirements After Consumption of a Nutritional Formula in Patients With Chewing/Swallowing Problems.
Official title: Evaluation of the Effect of the Consumption of a Hypercaloric/Hyperproteic Formula in the Coverage of Nutritional Requirements in Patients With Chewing/Swallowing Problems That Require a Shredded Diet.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deglutition Disorders
Nutritional Deficiency
Chew Problems
Swallowing Disorder
Keywords: Deglutition disorders
Nutritional deficiency
Chew problems
Swallowing disorder
Nutritional formula
Nutritional oral supplement
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Vegenat, S.A.
First posted: 2018-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of nutritional changes with regard to the nutritional requirements recommended
timeFrame: Up to one month
Secondary outcomes:
measure: Change from Baseline Anthropometric Parameters
timeFrame: Up to one month
measure: Change from Baseline Anthropometric Parameters
timeFrame: Up to one month
measure: 24h Dietary Recall Questionnaire
timeFrame: Up to one month
measure: Adverse Effects
timeFrame: Up to one month
measure: Sensory perception
timeFrame: Up to one month
measure: Functionality Variables
timeFrame: Up to one month
measure: Tolerance and adverse effects
timeFrame: Up to one month
measure: International Physical Activity Questionnaire
timeFrame: Up to one month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gómez Candela, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: