Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients at Nutritional Risk

Study Overview
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Brief Summary
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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.

Official Title
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Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients at Nutritional Risk Receiving Dietary Counseling: a Randomized, Controlled Trial

Conditions
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Nutritional Support

Intervention / Treatment
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* Dietary Supplement: Intensive nutritional counseling
* Other: Dietary counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive nutritional counseling<br>Dietary counseling + energy dense oral nutritional supplements | Dietary Supplement: Intensive nutritional counseling<br>* Dietary counseling + energy-dense oral nutritional supplements since admission<br>|
| Active Comparator: Dietary counseling<br>Dietary counseling | Other: Dietary counseling<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Change in phase angle as assessed by vectorial impedance analysis | 7 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |