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

Primary Purpose

Deglutition Disorders, Nutritional Deficiency, Chew Problems

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control Group (education, guidelines, recommendations)
Experimental Group (education, guidelines, 2 pckts diet, recommendations)
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Deglutition Disorders focused on measuring Deglutition disorders, Nutritional deficiency, Chew problems, Swallowing disorder, Nutritional formula, Nutritional oral supplement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute for Health Research IdiPAZ

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2018
Last Updated
June 10, 2022
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Vegenat, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03727191
Brief Title
Coverage of Requirements After Consumption of a Nutritional Formula in Patients With Chewing/Swallowing Problems.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborators
Vegenat, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders, Nutritional Deficiency, Chew Problems, Swallowing Disorder
Keywords
Deglutition disorders, Nutritional deficiency, Chew problems, Swallowing disorder, Nutritional formula, Nutritional oral supplement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group (education, guidelines, recommendations)
Intervention Description
Nutritional education and guidelines for the consumption of a completed shreded diet and recommendations for physical activity for one month.
Intervention Type
Other
Intervention Name(s)
Experimental Group (education, guidelines, 2 pckts diet, recommendations)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of nutritional changes with regard to the nutritional requirements recommended
Description
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 Outcome Measure Information:
Title
Change from Baseline Anthropometric Parameters
Description
Weight and Height to calcule BMI in kg/m2
Time Frame
Up to one month
Title
Change from Baseline Anthropometric Parameters
Description
Waist Circumference
Time Frame
Up to one month
Title
24h Dietary Recall Questionnaire
Description
Food and activity habits of people
Time Frame
Up to one month
Title
Adverse Effects
Description
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Time Frame
Up to one month
Title
Sensory perception
Description
Sensory Perception Scale
Time Frame
Up to one month
Title
Functionality Variables
Description
Force dynamometry hand
Time Frame
Up to one month
Title
Tolerance and adverse effects
Description
Tolerance and adverse effects questionnaire
Time Frame
Up to one month
Title
International Physical Activity Questionnaire
Description
Activity habits of people
Time Frame
Up to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gómez Candela, PhD, MS
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Health Research IdiPAZ
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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