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

NCT ID: NCT02763904

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-30
• Study Completion Date: 2024-07-30

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.

Conditions

Nutritional Support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive nutritional counseling

Dietary counseling + energy dense oral nutritional supplements

Group Type: EXPERIMENTAL

Intensive nutritional counseling

Intervention Type: DIETARY_SUPPLEMENT

Dietary counseling + energy-dense oral nutritional supplements since admission

Dietary counseling

Dietary counseling

Group Type: ACTIVE_COMPARATOR

Dietary counseling

Intervention Type: OTHER

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)

Interventions

Intensive nutritional counseling

Dietary counseling + energy-dense oral nutritional supplements since admission

Intervention Type: DIETARY_SUPPLEMENT

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emanuele Cereda

OTHER

Sponsor Role: lead

Responsible Party

Emanuele Cereda

Fondazione IRCCS Policlinico San Matteo di Pavia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emanuele Cereda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo

Riccardo Caccialanza, MD

Role: STUDY_CHAIR

Fondazione IRCCS Policlinico San Matteo

Locations

Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Countries

Italy

Other Identifiers

20150005564

Identifier Type: -

Identifier Source: org_study_id