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

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.

Conditions

• Nutritional Support

Interventions

DIETARY_SUPPLEMENT

Intensive nutritional counseling

Dietary counseling + energy-dense oral nutritional supplements since admission

OTHER

Dietary counseling

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)

Sponsors & Collaborators

• Emanuele Cereda

  lead OTHER

Principal Investigators

• Emanuele Cereda, MD, PhD · Fondazione IRCCS Policlinico San Matteo

• Riccardo Caccialanza, MD · Fondazione IRCCS Policlinico San Matteo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-30

Primary Completion

2024-07-24

Completion

2024-07-30

Countries

• Italy

Study Locations