Nutritional SupportNCT02763904
Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk
A study testing Intensive nutritional counseling and Dietary counseling in people with Nutritional Support, run by Emanuele Cereda at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nutritional Support
- What is being tested?
- Intensive nutritional counseling and Dietary counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2016to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nutritional Risk Score [NRS-2002] ≥3
- assessed within 48 hours since admission
- expected length of stay ≥7 days
- written informed consent
Who cannot join
- 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)
Show all 9Show fewer
- physician-based indication to the of disease-specific oral nutritional supplements (e.g. kidney failure or pressure ulcers)
- terminal illness
- unavailability to planned measurements
Trial locations and contacts
1 site in 1 country.
Italy1 site
Nutrition and Dietetics Service, Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
About this study
Official title: 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.
- Conditions
- Nutritional Support
- Being tested
- Intensive nutritional counseling, Dietary counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive nutritional counselingDietary supplement
Dietary counseling + energy-dense oral nutritional supplements since admission
Dietary counselingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Intensive nutritional counseling | Experimental | Dietary counseling + energy dense oral nutritional supplements Receives: Dietary Supplement: Intensive nutritional counseling |
| Dietary counseling | Active comparator | Dietary counseling Receives: Other: Dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Change in phase angle as assessed by vectorial impedance analysis
Measured: 7 days
Secondary outcomes (9)
Body composition
Change in phase angle as assessed by vectorial impedance analysis
Measured: 14 days
Body composition
Change in phase angle as assessed by vectorial impedance analysis
Measured: Hospital stay, an average of 17 days
Functional status
Change in handgrip strength as assessed by dynamometry
Measured: 7 days
Functional status
Change in handgrip strength as assessed by dynamometry
Measured: 14 days
Functional status
Change in handgrip strength as assessed by dynamometry
Measured: Hospital stay, an average of 17 days
Energy intake
Protein-calorie intake as assessed by serial 24-hour dietary recall
Measured: 7 days
Energy intake
Protein-calorie intake as assessed by serial 24-hour dietary recall
Measured: 14 days
Infections
Incidence of new infections during the hospital stay
Measured: Hospital stay, an average of 17 days
Adverse events
Gastrointestinal intolerance events
Measured: Hospital stay, an average of 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start30 Jul 2016
- Primary completion24 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional SupportStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuele Cereda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emanuele Cereda, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Emanuele Cereda, MD, PhD, Principal investigator, Fondazione IRCCS Policlinico San MatteoRiccardo Caccialanza, MD, Study chair, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763904
- Sponsor's protocol ID
- 20150005564
- Status last verified
- Nov 2024
- First submitted
- 3 May 2016
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Oral Nutritional Support in Hospitalized, Moderately Hypophagic Patients At Nutritional Risk Receiving Dietary Counseling: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02763904
- Acronym / sponsor ID
- 20150005564
- Conditions
- Nutritional Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Emanuele CeredaUniversity, hospital or other
- Study start
- 30 Jul 2016 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive nutritional counseling | Experimental | Dietary Supplement: Intensive nutritional counselingDietary counseling + energy dense oral nutritional supplements |
| Dietary counseling | Active comparator | Other: Dietary counselingDietary counseling |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nutritional Risk Score [NRS-2002] ≥3
- assessed within 48 hours since admission
- expected length of stay ≥7 days
- written informed consent
Key exclusion criteria (9 listed)
- age < 18 years
- ongoing or indication to artificial nutrition
- severe hypophagia (intake <50% of estimated requirements)
- scheduled for surgery
- indication to fasting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive nutritional counselingDietary counseling + energy-dense oral nutritional supplements since admission | Dietary supplement | Intensive nutritional counseling |
| Dietary counselingDietary 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) | Other | Dietary counseling |
Primary outcome
Body composition
Time frame: 7 days
Change in phase angle as assessed by vectorial impedance analysis
9 secondary outcomes
Body composition
Time frame: 14 days
Body composition
Time frame: Hospital stay, an average of 17 days
Functional status
Time frame: 7 days
Functional status
Time frame: 14 days
Functional status
Time frame: Hospital stay, an average of 17 days
Energy intake
Time frame: 7 days
Energy intake
Time frame: 14 days
Infections
Time frame: Hospital stay, an average of 17 days
Adverse events
Time frame: Hospital stay, an average of 17 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Nutritional Support
RecruitingObservational study
Effect of Protein Dosage on Persistent Acute Renal Failure in Critically Ill Patients.
Acute Kidney Failure, Critical Illness
Not yet recruiting
Enteral Versus Parenteral Nutrition During Recovery After Shock
Shock, Critical Illness
Recruiting
Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)
Malnutrition, Cancer-related Malnutrition
Not yet recruiting
Training Program for PEG Caregivers: A Structured Intervention Study
Percutaneous Endoscopic Gastrostomy (PEG), Training
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuele Cereda, MD, PhD principal investigator
Fondazione IRCCS Policlinico San Matteo
Riccardo Caccialanza, MD study chair
Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive nutritional counseling and Dietary counseling in people with Nutritional Support, run by Emanuele Cereda at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.