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Completed

NCT Number: NCT03727191

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

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

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Key information

Conditions

Deglutition Disorders Chew Problems Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Malnutrition Nutrition Disorders Nutritional Deficiency Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Swallowing Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Vegenat, S.A.

Registry information

Official study 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.

Acronym: VEGENAT MED

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 1, 2018
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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