Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
NCT Number: NCT02763904
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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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Pavia, 27100, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary counseling + energy-dense oral nutritional supplements since admission
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)
Time frame: 7 days
Change in phase angle as assessed by vectorial impedance analysis
Time frame: 14 days
Change in phase angle as assessed by vectorial impedance analysis
Time frame: Hospital stay, an average of 17 days
Change in phase angle as assessed by vectorial impedance analysis
Time frame: 7 days
Change in handgrip strength as assessed by dynamometry
Time frame: 14 days
Change in handgrip strength as assessed by dynamometry
Time frame: Hospital stay, an average of 17 days
Change in handgrip strength as assessed by dynamometry
Time frame: 7 days
Protein-calorie intake as assessed by serial 24-hour dietary recall
Time frame: 14 days
Protein-calorie intake as assessed by serial 24-hour dietary recall
Time frame: Hospital stay, an average of 17 days
Incidence of new infections during the hospital stay
Time frame: Hospital stay, an average of 17 days
Gastrointestinal intolerance events
Emanuele Cereda
Other
Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk Receiving Dietary Counseling: a Randomized, Controlled Trial
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