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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-06-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Deglutition Disorders Nutritional Deficiency Chew Problems Swallowing Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Control Group (education, guidelines, recommendations)

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No