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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727191
Recruitment Status : Active, not recruiting
First Posted : November 1, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Vegenat, S.A.
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

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

Condition or disease Intervention/treatment Phase
Deglutition Disorders Nutritional Deficiency Chew Problems Swallowing Disorder Other: Control Group (education, guidelines, recommendations) Other: Experimental Group (education, guidelines, 2 pckts diet, recommendations) Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Active Comparator: Control Group
Nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity.
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: Experimental Group
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.
Other: 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.




Primary Outcome Measures :
  1. Percentage of nutritional changes with regard to the nutritional requirements recommended [ Time Frame: Up to one month ]
    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 :
  1. Change from Baseline Anthropometric Parameters [ Time Frame: Up to one month ]
    Weight and Height to calcule BMI in kg/m2

  2. Change from Baseline Anthropometric Parameters [ Time Frame: Up to one month ]
    Waist Circumference

  3. 24h Dietary Recall Questionnaire [ Time Frame: Up to one month ]
    Food and activity habits of people

  4. Adverse Effects [ Time Frame: Up to one month ]
    Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)

  5. Sensory perception [ Time Frame: Up to one month ]
    Sensory Perception Scale

  6. Functionality Variables [ Time Frame: Up to one month ]
    Force dynamometry hand

  7. Tolerance and adverse effects [ Time Frame: Up to one month ]
    Tolerance and adverse effects questionnaire

  8. International Physical Activity Questionnaire [ Time Frame: Up to one month ]
    Activity habits of people



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727191


Locations
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Spain
Institute for Health Research IdiPAZ
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Vegenat, S.A.
Investigators
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Principal Investigator: Carmen Gómez Candela, PhD, MS Hospital Universitario La Paz

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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03727191     History of Changes
Other Study ID Numbers: 4985
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Deglutition disorders
Nutritional deficiency
Chew problems
Swallowing disorder
Nutritional formula
Nutritional oral supplement
Additional relevant MeSH terms:
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Deglutition Disorders
Malnutrition
Disease
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Nutrition Disorders