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

NCT02763904 | Completed

• 1 other identifier: 20150005564
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Body composition

  Change in phase angle as assessed by vectorial impedance analysis

  7 days

Secondary Outcomes (9)

• Body composition

  14 days

• Body composition

  Hospital stay, an average of 17 days

• Functional status

  7 days

• Functional status

  14 days

• Functional status

  Hospital stay, an average of 17 days

Study Arms (2)

Intensive nutritional counseling

EXPERIMENTAL

Dietary counseling + energy dense oral nutritional supplements

Dietary Supplement: Intensive nutritional counseling

Dietary counseling

ACTIVE COMPARATOR

Dietary counseling

Other: Dietary counseling

Interventions

Intensive nutritional counseling DIETARY_SUPPLEMENT

Dietary counseling + energy-dense oral nutritional supplements since admission

Intensive nutritional counseling

Dietary counseling 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)

Dietary counseling

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nutritional Risk Score \[NRS-2002\] ≥3
• assessed within 48 hours since admission
• expected length of stay ≥7 days
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Emanuele Cereda: lead

Study Sites (1)

Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Emanuele Cereda, MD, PhD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

• Riccardo Caccialanza, MD

  Fondazione IRCCS Policlinico San Matteo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fondazione IRCCS Policlinico San Matteo di Pavia

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 5, 2016
• Study Start: July 30, 2016
• Primary Completion: July 24, 2024
• Study Completion: July 30, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

IT (1)