NCT03727191

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

June 14, 2022

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

October 30, 2018

Last Update Submit

June 10, 2022

Conditions

Deglutition DisordersNutritional DeficiencyChew ProblemsSwallowing Disorder

Keywords

Deglutition disordersNutritional deficiencyChew problemsSwallowing disorderNutritional formulaNutritional oral supplement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change from Baseline Anthropometric Parameters

    Up to one month

  • Change from Baseline Anthropometric Parameters

    Up to one month

  • 24h Dietary Recall Questionnaire

    Up to one month

  • Adverse Effects

    Up to one month

  • Sensory perception

    Up to one month

  • +3 more secondary outcomes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Control Group (education, guidelines, recommendations)

Experimental Group

EXPERIMENTAL

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)

Interventions

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.

Control Group
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.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Deglutition DisordersMalnutrition

Interventions

Control GroupsEducational StatusGuidelines as Topic

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsSocioeconomic FactorsPopulation CharacteristicsQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Carmen Gómez Candela, PhD, MS

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 1, 2018

Study Start

May 1, 2018

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

June 14, 2022

Record last verified: 2019-02

Locations

ES(1)