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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive nutritional counseling | Experimental | Dietary counseling + energy dense oral nutritional supplements |
|
| Dietary counseling | Active Comparator | Dietary counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive nutritional counseling | Dietary Supplement | Dietary counseling + energy-dense oral nutritional supplements since admission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Change in phase angle as assessed by vectorial impedance analysis | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Change in phase angle as assessed by vectorial impedance analysis | 14 days |
| Body composition | Change in phase angle as assessed by vectorial impedance analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Cereda, MD, PhD | Fondazione IRCCS Policlinico San Matteo | Principal Investigator |
| Riccardo Caccialanza, MD | Fondazione IRCCS Policlinico San Matteo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Dietary counseling | Other | 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) |
|
| Hospital stay, an average of 17 days |
| Functional status | Change in handgrip strength as assessed by dynamometry | 7 days |
| Functional status | Change in handgrip strength as assessed by dynamometry | 14 days |
| Functional status | Change in handgrip strength as assessed by dynamometry | Hospital stay, an average of 17 days |
| Energy intake | Protein-calorie intake as assessed by serial 24-hour dietary recall | 7 days |
| Energy intake | Protein-calorie intake as assessed by serial 24-hour dietary recall | 14 days |
| Infections | Incidence of new infections during the hospital stay | Hospital stay, an average of 17 days |
| Adverse events | Gastrointestinal intolerance events | Hospital stay, an average of 17 days |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |