Chew Problems, Deglutition Disorders, Nutritional Deficiency, Swallowing Disorder
Conditions
Keywords
Deglutition disorders, Nutritional deficiency, Chew problems, Swallowing disorder, Nutritional formula, Nutritional oral supplement
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.
Interventions
OTHERControl Group (education, guidelines, recommendations)
Nutritional education and guidelines for the consumption of a completed shreded diet and recommendations for physical activity for one month.
OTHERExperimental 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.
Sponsors
Vegenat, S.A.
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 24h Dietary Recall Questionnaire | Up to one month | Food and activity habits of people |
| Adverse Effects | Up to one month | Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders) |
| Sensory perception | Up to one month | Sensory Perception Scale |
| Change from Baseline Anthropometric Parameters | Up to one month | Weight and Height to calcule BMI in kg/m2 |
| Tolerance and adverse effects | Up to one month | Tolerance and adverse effects questionnaire |
| International Physical Activity Questionnaire | Up to one month | Activity habits of people |
| Functionality Variables | Up to one month | Force dynamometry hand |
Countries
Spain
Outcome results
None listed