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

Deglutition Disorders Clinical Trial

— VEGENAT MED  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727191
• Other study ID #: HULP 4985
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: February 2019
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chew Problems
• Deglutition Disorders
• Disease
• Malnutrition
• Nutritional Deficiency
• Swallowing Disorder

Intervention

Other:
• Control Group (education, guidelines, recommendations)
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)
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.

Locations

Country	Name	City	State
Spain	Institute for Health Research IdiPAZ	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Vegenat, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to one month
Secondary	Change from Baseline Anthropometric Parameters	Weight and Height to calcule BMI in kg/m2	Up to one month
Secondary	Change from Baseline Anthropometric Parameters	Waist Circumference	Up to one month
Secondary	24h Dietary Recall Questionnaire	Food and activity habits of people	Up to one month
Secondary	Adverse Effects	Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)	Up to one month
Secondary	Sensory perception	Sensory Perception Scale	Up to one month
Secondary	Functionality Variables	Force dynamometry hand	Up to one month
Secondary	Tolerance and adverse effects	Tolerance and adverse effects questionnaire	Up to one month
Secondary	International Physical Activity Questionnaire	Activity habits of people	Up to one month