MalnutritionNUTRISKONCT06590350
Individualized NUTRItional RISK and Oriented Nutritional Support
An observational study of Malnutrition, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Clinical nutrition counseling
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jun 2024to 1 Oct 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at risk of malnutrition by default (NRS-2002 ≥3) admitted to the Admission Room Departmental Simple Operating Unit of the A. Gemelli Polyclinic Foundation in Rome.
Who may be able to join
- Age >18 years
- NRS-2002 ≥3
- Length of stay > 4 days
- Informed consent to participate in the study
Who cannot join
- NRS-2002 <3
- Length of stay < or = 4 days
- Absence of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention.
Read the detailed description
Patients admitted from the date following the date of approval of the protocol for the following 12 months will be enrolled at the Departmental Simple Operating Unit Admission Room of the Policlinico Universitario A. Gemelli and who have undergone NRS-2002 screening.
Data only of patients with NRS-2002 > 3 admitted will be considered and extracted via the Foundation's computer system (Trackcare).
Patients will be managed by caregivers who spontaneously request (as is the case to date) nutritional counseling. Therefore, the study will not change current clinical practice.
Two cohorts will be formed and compared:
Cohort 1: patients at risk of malnutrition (NRS-2002 ≥ 3) who received clinical nutrition counseling within 72 hours of ward admission.
Cohort 2: patients at risk of malnutrition (NRS-2002 ≥ 3) who did NOT receive clinical nutrition counseling beyond 72 hours after ward admission.
Currently, at Fondazione Policlinico Universitario A. Gemelli, the Clinical Nutrition Unit is approached on an ad hoc basis by the individual ward attending physician, without a specific procedure: the physician calls in Clinical Nutrition specialists for consultation if in his or her judgment the patient needs nutritional support. The formation of the two cohorts will be entirely spontaneous, that is, according to current clinical practice, given by the judgment of the ward treating physician. In a spontaneous manner, two cohorts will be formed among patients at risk of malnutrition (NRS-2002 ≥ 3), one of which will have received specialized nutritional support within 72 hours, the other will not. Only patients at risk of malnutrition will be tracked, highlighting outcomes among those in this category who received the targeted intervention at the appropriate times, versus those who did not. The enrollment department is the same for all patients.
- Conditions
- Malnutrition
- Being tested
- Clinical nutrition counseling
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical nutrition counselingOther
In the first phase, all patients admitted to the Departmental Simple Operating Unit Admission Room of Policlinico Universitario A. Gemelli will be screened for NRS-2002 upon admission.
Only patients with NRS-2002 ≥ 3 will subsequently be tracked via the Foundation's computer system (TrackCare®).
The patients will be managed by caregivers who may spontaneously request nutritional counseling, as is currently the case.
Patient data (laboratory tests, medical history, reason for admission, any instrumental test reports) and clinical outcomes (average length of hospitalization, complications, antibiotic therapy use, intensive care admission, mortality, re-hospitalization within 30 days) will be obtained from the Foundation's computer system (TrackCare®) and recorded in a dedicated Excel® spreadsheet.
Costs related to hospitalization and management of any complications will also be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Cohort who received clinical nutrition counseling <72 hours | Patients at risk of malnutrition who received clinical nutrition counseling within 72 hours. Receives: Other: Clinical nutrition counseling | |
| Cohort who did NOT received clinical nutrition counseling <72 hours | Patients at risk of malnutrition who did NOT receive clinical nutrition counseling within 72 hours. Receives: Other: Clinical nutrition counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the duration of hospitalization
Difference in the overall length of stay in patients at risk of malnutrition (NRS-2002 ≥ 3) who received nutrition counseling within 72 hours of ward admission compared to the group of patients at risk who did not receive counseling within 72 hours.
Measured: 12 months
Secondary outcomes (3)
Differences in the number of infectious complications
Difference in the overall length of stay in patients at risk of malnutrition (NRS-2002 ≥ 3) who received nutrition counseling within 72 hours of ward admission compared to the group of patients at risk who did not receive counseling within 72 hours.
Measured: 12 months
Frequency of adherence to diet and AFMS proposed at visit
requency of adherence to the prescribed diet and AFMS (Artificial Feeding and Medical Support) proposed during the visit.
Measured: 12 months
Differences in hospitalization costs for the healthcare
Differences in hospitalization costs for the healthcare facility among patients at risk of malnutrition who received nutritional counseling within 72 hours of admission compared to the group of patients at risk who did not receive counseling within 72 hours of ward entry.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start4 Jun 2024
- Primary completion31 Dec 2024
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emanuele Rinninella, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590350
- Sponsor's protocol ID
- 6407 - NUTRISKO
- Acronym
- NUTRISKO
- Status last verified
- Sep 2026
- First submitted
- 29 Mar 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized NUTRItional RISK and Oriented Nutritional Support
- ClinicalTrials.gov ID
- NCT06590350
- Acronym / sponsor ID
- NUTRISKO / 6407 - NUTRISKO
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- 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.
The objective of this study is to evaluate whether, in patients who are given early nutritional counseling, there is a reduction in the length of hospitalization and the rate of nosocomial infections, resulting in a decrease in inpatient costs, compared with patients who do not benefit from this intervention.
Detailed description
Patients admitted from the date following the date of approval of the protocol for the following 12 months will be enrolled at the Departmental Simple Operating Unit Admission Room of the Policlinico Universitario A. Gemelli and who have undergone NRS-2002 screening.
Data only of patients with NRS-2002 > 3 admitted will be considered and extracted via the Foundation's computer system (Trackcare).
Patients will be managed by caregivers who spontaneously request (as is the case to date) nutritional counseling. Therefore, the study will not change current clinical practice.
Two cohorts will be formed and compared:
Cohort 1: patients at risk of malnutrition (NRS-2002 ≥ 3) who received clinical nutrition counseling within 72 hours of ward admission.
Cohort 2: patients at risk of malnutrition (NRS-2002 ≥ 3) who did NOT receive clinical nutrition counseling beyond 72 hours after ward admission.
Currently, at Fondazione Policlinico Universitario A. Gemelli, the Clinical Nutrition Unit is approached on an ad hoc basis by the individual ward attending physician, without a specific procedure: the physician calls in Clinical Nutrition specialists for consultation if in his or her judgment the patient needs nutritional support. The formation of the two cohorts will be entirely spontaneous, that is, according to current clinical practice, given by the judgment of the ward treating physician. In a spontaneous manner, two cohorts will be formed among patients at risk of malnutrition (NRS-2002 ≥ 3), one of which will have received specialized nutritional support within 72 hours, the other will not. Only patients at risk of malnutrition will be tracked, highlighting outcomes among those in this category who received the targeted intervention at the appropriate times, versus those who did not. The enrollment department is the same for all patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort who received clinical nutrition counseling <72 hours | – | Other: Clinical nutrition counselingPatients at risk of malnutrition who received clinical nutrition counseling within 72 hours. |
| Cohort who did NOT received clinical nutrition counseling <72 hours | – | Other: Clinical nutrition counselingPatients at risk of malnutrition who did NOT receive clinical nutrition counseling within 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at risk of malnutrition by default (NRS-2002 ≥3) admitted to the Admission Room Departmental Simple Operating Unit of the A. Gemelli Polyclinic Foundation in Rome.
Key inclusion criteria (4 listed)
- Age >18 years
- NRS-2002 ≥3
- Length of stay > 4 days
- Informed consent to participate in the study
Key exclusion criteria (3 listed)
- NRS-2002 <3
- Length of stay < or = 4 days
- Absence of informed consent
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 |
|---|---|---|
| Clinical nutrition counselingIn the first phase, all patients admitted to the Departmental Simple Operating Unit Admission Room of Policlinico Universitario A. Gemelli will be screened for NRS-2002 upon admission. Only patients with NRS-2002 ≥ 3 will subsequently be tracked via the Foundation's computer system (TrackCare®). The patients will be managed by caregivers who may spontaneously request nutritional counseling, as is currently the case. Patient data (laboratory tests, medical history, reason for admission, any instrumental test reports) and clinical outcomes (average length of hospitalization, complications, antibiotic therapy use, intensive care admission, mortality, re-hospitalization within 30 days) will be obtained from the Foundation's computer system (TrackCare®) and recorded in a dedicated Excel® spreadsheet. Costs related to hospitalization and management of any complications will also be assessed. | Other | Cohort who did NOT received clinical nutrition counseling <72 hours, Cohort who received clinical nutrition counseling <72 hours |
Primary outcome
Difference in the duration of hospitalization
Time frame: 12 months
Difference in the overall length of stay in patients at risk of malnutrition (NRS-2002 ≥ 3) who received nutrition counseling within 72 hours of ward admission compared to the group of patients at risk who did not receive counseling within 72 hours.
3 secondary outcomes
Differences in the number of infectious complications
Time frame: 12 months
Frequency of adherence to diet and AFMS proposed at visit
Time frame: 12 months
Differences in hospitalization costs for the healthcare
Time frame: 12 months
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 24 Sep 2026.
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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 Rinninella principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 3 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 24 Sep 2026. 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?
Difference in the duration of hospitalization (time frame: 12 months). 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 24 Sep 2026; AzTrials last refreshed its copy on 4 Nov 2026.