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

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.

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

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders; Nutritional Deficiency; Chew Problems; Swallowing Disorder
• Intervention / Treatment: Other: Control Group (education, guidelines, recommendations); Other: Experimental Group (education, guidelines, 2 pckts diet, recommendations)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Institute for Health Research IdiPAZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Vegenat, S.A.
• Investigators: Principal Investigator: Carmen Gómez Candela, PhD, MS, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Deglutition disorders; Nutritional deficiency; Chew problems; Swallowing disorder; Nutritional formula; Nutritional oral supplement
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Nutrition Disorders; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Disease; Deglutition Disorders; Malnutrition
• Other Study ID Numbers: HULP 4985

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No