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

Nutritional Support Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02763904
• Other study ID #: 20150005564
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: May 2021

Study information

• Verified date: February 2021
• Source: IRCCS Policlinico S. Matteo
• Contact: Emanuele Cereda, MD, PhD
• Phone: +390382501484
• Email: e.cereda[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Support

Intervention

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)

Locations

Country	Name	City	State
Italy	Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Change in phase angle as assessed by vectorial impedance analysis	7 days
Secondary	Body composition	Change in phase angle as assessed by vectorial impedance analysis	14 days
Secondary	Body composition	Change in phase angle as assessed by vectorial impedance analysis	Hospital stay, an average of 17 days
Secondary	Functional status	Change in handgrip strength as assessed by dynamometry	7 days
Secondary	Functional status	Change in handgrip strength as assessed by dynamometry	14 days
Secondary	Functional status	Change in handgrip strength as assessed by dynamometry	Hospital stay, an average of 17 days
Secondary	Energy intake	Protein-calorie intake as assessed by serial 24-hour dietary recall	7 days
Secondary	Energy intake	Protein-calorie intake as assessed by serial 24-hour dietary recall	14 days
Secondary	Infections	Incidence of new infections during the hospital stay	Hospital stay, an average of 17 days
Secondary	Adverse events	Gastrointestinal intolerance events	Hospital stay, an average of 17 days