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| Name | Class |
|---|---|
| Vegenat, S.A. | INDUSTRY |
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Effect of a nutritional formula on the nutritional requirements in patients with chewing/swallowing problems during one month
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gómez Candela, PhD, MS | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Health Research IdiPAZ | Madrid | 28046 | Spain |
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| 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. |
|
| 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 |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| D004522 | Educational Status |
| D017408 | Guidelines as Topic |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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