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

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Chew Problems; Swallowing Disorder; Nutritional Deficiency; Deglutition Disorders

Treatments: Other: Control Group (education, guidelines, recommendations); Other: Experimental Group (education, guidelines, 2 pckts diet, recommendations)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03727191

HULP 4985

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Other: Control Group (education, guidelines, recommendations)

Experimental Group

Experimental group

Description:

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.

Treatment:

Other: Experimental Group (education, guidelines, 2 pckts diet, recommendations)