Nutritional Support
Conditions
Brief summary
Protein-calorie malnutrition is a frequent comorbidity in hospitalized patients and there is evidence that the nutritional status may influence the response to drug treatment, mortality, susceptibility to infections, the patient's functional status, duration of hospital stay and, consequently, overall healthcare costs. The causes of malnutrition are manifold. The underlying disease may in fact lead to an increase in the patient's energy needs, whether or not associated with a reduction in caloric intake. The same therapeutic treatments can further worsen the energy balance without considering that the patient can be kept fasting for the execution of some diagnostic procedures. Therefore, a further deterioration of nutritional status during hospitalization could occur. International guidelines underline the utility to set a nutritional support whenever this is necessary, not only to prevent or treat malnutrition but also improve clinical outcomes. In this perspective, the improvement of oral diet and the use of oral nutritional supplements (ONS) represent the first-line strategy of intervention. Previous studies have shown that nutritional counseling, with or without the use of ONS, in patients with chronic disease is able to improve the calorie-protein intake, prevent deterioration of nutritional status, as well as to increase to a certain extent body weight. Particularly, energy-dense are more effective in increase energy intake. These data have highlighted the importance of a proper evaluation of the nutritional status of early detection of patients who could benefit of nutritional support. However, the independent role of the ONS in improving clinical outcome still needs to be established.
Interventions
DIETARY_SUPPLEMENTIntensive nutritional counseling
Dietary counseling + energy-dense oral nutritional supplements since admission
OTHERDietary counseling
Dietary counseling alone. In case of inadequate energy intake patients will receive oral nutritional supplements since day 8 from admission (after the evaluation of the primary end point)
Sponsors
Emanuele Cereda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Nutritional Risk Score \[NRS-2002\] ≥3 * assessed within 48 hours since admission * expected length of stay ≥7 days * written informed consent
Exclusion criteria
* age \< 18 years * ongoing or indication to artificial nutrition * severe hypophagia (intake \<50% of estimated requirements) * scheduled for surgery * indication to fasting * physician-based contra-indication to use of liquid oral nutritional supplements (vomitus, severe nausea, diarrhea, dysphagia) * physician-based indication to the of disease-specific oral nutritional supplements (e.g. kidney failure or pressure ulcers) * terminal illness * unavailability to planned measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 7 days | Change in phase angle as assessed by vectorial impedance analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 14 days | Change in phase angle as assessed by vectorial impedance analysis |
| Functional status | 7 days | Change in handgrip strength as assessed by dynamometry |
| Energy intake | 7 days | Protein-calorie intake as assessed by serial 24-hour dietary recall |
| Infections | Hospital stay, an average of 17 days | Incidence of new infections during the hospital stay |
| Adverse events | Hospital stay, an average of 17 days | Gastrointestinal intolerance events |
Countries
Italy
Outcome results
None listed