An interventional study of Intensive nutritional counseling and Dietary counseling in Nutritional Support, sponsored by Emanuele Cereda. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Emanuele Cereda · Not applicable, Interventional, and Treatment
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.
Emanuele Cereda is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary counseling + energy dense oral nutritional supplements
Dietary Supplement: Intensive nutritional counseling
Dietary counseling
Other: Dietary counseling
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)
Body composition
Change in phase angle as assessed by vectorial impedance analysis
Time frame: 7 days
Body composition
Change in phase angle as assessed by vectorial impedance analysis
Time frame: 14 days
Body composition
Change in phase angle as assessed by vectorial impedance analysis
Time frame: Hospital stay, an average of 17 days
Functional status
Change in handgrip strength as assessed by dynamometry
Time frame: 7 days
Functional status
Change in handgrip strength as assessed by dynamometry
Time frame: 14 days
Functional status
Change in handgrip strength as assessed by dynamometry
Time frame: Hospital stay, an average of 17 days
Energy intake
Protein-calorie intake as assessed by serial 24-hour dietary recall
Time frame: 7 days
Energy intake
Protein-calorie intake as assessed by serial 24-hour dietary recall
Time frame: 14 days
Infections
Incidence of new infections during the hospital stay
Time frame: Hospital stay, an average of 17 days
Adverse events
Gastrointestinal intolerance events
Time frame: Hospital stay, an average of 17 days
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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