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

I

IRCCS Policlinico S. Matteo

Status

Unknown

Conditions

Nutritional Support

Treatments

Dietary Supplement: Intensive nutritional counseling
Other: Dietary counseling

Study type

Interventional

Funder types

Other

Identifiers

NCT02763904
20150005564

Details and patient eligibility

About

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.

Enrollment

286 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

286 participants in 2 patient groups

Intensive nutritional counseling
Experimental group
Description:
Dietary counseling + energy dense oral nutritional supplements
Treatment:
Dietary Supplement: Intensive nutritional counseling
Dietary counseling
Active Comparator group
Description:
Dietary counseling
Treatment:
Other: Dietary counseling

Trial contacts and locations

1

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Central trial contact

Emanuele Cereda, MD, PhD

Data sourced from clinicaltrials.gov

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