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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nutritional Support
• Intervention / Treatment: Dietary supplement: Intensive nutritional counseling; Other: Dietary counseling

• Study Type: Interventional
• Enrollment (Anticipated): 286
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emanuele Cereda, MD, PhD; Phone Number: +390382501484; Email: e.cereda@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
    • Contact: Emanuele Cereda, MD, PhD; Phone Number: 00390382501615; Email: e.cereda@smatteo.pv.it
    • Principal Investigator: Emanuele Cereda, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive nutritional counseling; Dietary counseling + energy dense oral nutritional supplements	Dietary supplement: Intensive nutritional counseling; Dietary counseling + energy-dense oral nutritional supplements since admission
Active Comparator: Dietary counseling	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Emanuele Cereda, MD, PhD, Fondazione IRCCS Policlinico San Matteo; Study Chair: Riccardo Caccialanza, MD, Fondazione IRCCS Policlinico San Matteo

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20150005564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided