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Completed

NCT Number: NCT02763904

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

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive nutritional counseling

Dietary Supplement

Dietary counseling + energy-dense oral nutritional supplements since admission

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)

Primary outcomes

  1. Body composition

    Time frame: 7 days

    Change in phase angle as assessed by vectorial impedance analysis

Secondary outcomes

  1. Body composition

    Time frame: 14 days

    Change in phase angle as assessed by vectorial impedance analysis

  2. Body composition

    Time frame: Hospital stay, an average of 17 days

    Change in phase angle as assessed by vectorial impedance analysis

  3. Functional status

    Time frame: 7 days

    Change in handgrip strength as assessed by dynamometry

  4. Functional status

    Time frame: 14 days

    Change in handgrip strength as assessed by dynamometry

  5. Functional status

    Time frame: Hospital stay, an average of 17 days

    Change in handgrip strength as assessed by dynamometry

  6. Energy intake

    Time frame: 7 days

    Protein-calorie intake as assessed by serial 24-hour dietary recall

  7. Energy intake

    Time frame: 14 days

    Protein-calorie intake as assessed by serial 24-hour dietary recall

  8. Infections

    Time frame: Hospital stay, an average of 17 days

    Incidence of new infections during the hospital stay

  9. Adverse events

    Time frame: Hospital stay, an average of 17 days

    Gastrointestinal intolerance events

Sponsors and collaborators

Lead sponsor

Emanuele Cereda

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
May 5, 2016
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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