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

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

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.

Official Title
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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.

Conditions
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Deglutition Disorders, Chew Problems, Nutritional Deficiency, Swallowing Disorder

Intervention / Treatment
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* Other: Control Group (education, guidelines, recommendations)
* Other: Experimental Group (education, guidelines, 2 pckts diet, recommendations)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity. | Other: Control Group (education, guidelines, recommendations)<br>* Nutritional education and guidelines for the consumption of a completed shreded diet and recommendations for physical activity for one month.<br>|
| Experimental: Experimental Group<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deglutition disorders, Nutritional deficiency, Chew problems, Swallowing disorder, Nutritional formula, Nutritional oral supplement