Clinical trial NCT02763904: Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk
Official title: Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk Receiving Dietary Counseling: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Support
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body composition
timeFrame: 7 days
Secondary outcomes:
measure: Body composition
timeFrame: 14 days
measure: Body composition
timeFrame: Hospital stay, an average of 17 days
measure: Functional status
timeFrame: 7 days
measure: Functional status
timeFrame: 14 days
measure: Functional status
timeFrame: Hospital stay, an average of 17 days
measure: Energy intake
timeFrame: 7 days
measure: Energy intake
timeFrame: 14 days
measure: Infections
timeFrame: Hospital stay, an average of 17 days
measure: Adverse events
timeFrame: Hospital stay, an average of 17 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Emanuele Cereda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Riccardo Caccialanza, MD
role: STUDY_CHAIR
References: