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

Not Applicable

Completed

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

• Registration Number: NCT03727191
• Lead Sponsor: 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

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 Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-01
• Status Verified: 2019-02
• Primary Completion: 2019-12-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	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 (One salted packet for lunch/dinner and one sweet packet for breakfast/afternoon snack) and recommendations for physical activity for one month.
Control Group	Control Group (education, guidelines, recommendations)	Nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity.

Primary Outcome Measures

Name	Time	Method
Percentage of nutritional changes with regard to the nutritional requirements recommended	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

Name	Time	Method
24h Dietary Recall Questionnaire	Up to one month	Food and activity habits of people
Change from Baseline Anthropometric Parameters	Up to one month	Waist Circumference
Adverse Effects	Up to one month	Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Tolerance and adverse effects	Up to one month	Tolerance and adverse effects questionnaire
Functionality Variables	Up to one month	Force dynamometry hand
International Physical Activity Questionnaire	Up to one month	Activity habits of people
Sensory perception	Up to one month	Sensory Perception Scale

Trial Locations

Locations (1)

Institute for Health Research IdiPAZ; 🇪🇸 Madrid, Spain