ICU PatientsDETAILNCT07149246
The Effect of a 6-month Dietitian-tailored Nutrition Intervention to Patients With Critical Illness (DETAIL)
A study testing Nutrition intervention in people with ICU Patients and Nutrition Intake, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
This research project aims to study the effect of optimal and individualised nutrition to patients with critical illness during the intensive care unit (ICU) and hospital admission, and until six months after admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients, Nutrition Intake, Critical Illness
- What is being tested?
- Nutrition intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
None listed.
Who cannot join
- Death is imminent in the next 96 hours or there is a current treatment limitation in place or the patient is unlikely to survive to 180 days due to underlying/chronic illness
- Dialysis dependent chronic renal failure
- Suspected or known pregnancy
- Wheelchair user
- Cognitive impairment in which intervention is considered not appropriate
- Eating disorders -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
University Hospital of North Norway
Tromsø, 9037
Anders Benjamin Kildal, MD, PHD, +47 77798928, anders.benjamin.kildal@unn.no
About this study
Official title: The Effect of a 6-month DiEtitian-TAILored Nutrition Intervention Compared to Usual Care in Patients With Critical Illness. A Single Center Prospective Intervention Study
This research project aims to study the effect of optimal and individualised nutrition to patients with critical illness during the intensive care unit (ICU) and hospital admission, and until six months after admission. The investigators want to describe and compare the usual care with a dietitian-tailored nutrition care. The hypothesis is that dietitian-tailored nutrition care will result in a higher mean energy intake compared to usual care.
Read the detailed description
The study will recruit patients with critical illness in one of two groups. Group one will receive standard nutrition care following the current local guidelines. Group two will receive frequent follow-up by a clinical dietitian from inclusion and until six months from admission. The dietitian will be responsible for the nutrition administered to the patient during hospital admission and will have consultations with the patients after discharge. The patients in group two will receive individualized nutrition care and recommendations.
In addition to outcome measures regarding nutrition, the patients can choose if they want to perform physical tests and blood tests as well, but that part of the study is optional. In both groups, outcome measures will be collected at day ten, 30, 90 and 180 days after admission to the ICU. The collection of data will occur even though the patients have been discharged from the hospital, either to their home or another health care facility.
The aim is to study the effect of optimal and individualised nutrition to patients with critical illness during the ICU and hospital admission, and until six months after admission. Firstly, the investigators want to describe the usual care and progression of the patients during the first six months after hospital admission. Secondly, the investigators want to see if frequent follow-up by a clinical dietitian can increase nutritional intake during the same period.
The hypothesis is that dietitian-tailored nutrition care will result in a higher mean energy intake compared to usual care, and that this will further impact other aspects, such as quality of life and physical function.
- Conditions
- ICU Patients, Nutrition Intake, Critical Illness
- Being tested
- Nutrition intervention
- Keywords
- Nutrition, Energy intake, Protein intake, ICU, Dietitian
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition interventionOther
Frequent follow-up from a dietitian during ICU and hospital stay, and after discharge, up to 6 months after ICU admission.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Not described |
| Nutrition intervention | Experimental | A 6-month Dietitian-tailored nutrition intervention Receives: Other: Nutrition intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean energy intake
Mean energy intake from day 10 to the end of follow-up of 6 months.
Measured: Up to 6 months
Secondary outcomes (14)
Protein intake
Mean protein intake from day 10 to the end of follow-up of 6 months.
Measured: Up to 6 months
Nutrition intake
Energy and protein intake on each measurement point, Energy and protein intake by location (intensive care unit and ward), Energy and protein intake delivered by nutrition therapy
Measured: Day 10, day 30, day 90 and day 180
Nutrition risk during overall follow-up
Assessed with Nutrition Risk Screening 2002 (NRS-2002) at all measure time points, where the score 0-2 indicate no nutrition risk, and a score > 3 indicate nutrition risk.
Measured: Baseline, day 10, day 30, day 90 and day 180
Nutrition risk during ICU admission
Assessed with the modified Nutrition Risk in Critically Ill (mNUTRIC) score, ranging from a minimum value of 0 and a maximum value of 9. 0-4 points indicate a low malnutrition risk, 5-9 points indicate patients at high nutrition risk which are the most likely to benefit from aggressive nutrition therapy.
Measured: ICU admission up to 6 months
Health related quality of life
Assessed using the European Quality Of Life 5 Dimensions (EQ-5D) descriptive system. Each dimension has 5 levels ranging from no problems (1) to extreme problems (5), there is no overall score.
Measured: Day 10, day 30, day 90 and day 180
Self-rated health state
Self-rated by the participants using the European Quality Of Life Visual Analogue Scale (EQ-VAS). The VAS ranges from "The worst health you can imagine" (0) to "The best health you can imagine" (100).
Measured: Day 10, day 30, day 90 and day 180
Frailty
Assessed with clinical frailty scale (CFS), which is an ordinal scale with nine steps from very fit (1) to terminally ill (9).
Measured: Baseline, day 10, day 30, day 90 and day 180
Mobility
Assessed during intensive care unit (ICU) admission using the 11-category ICU Mobility Scale, with 10 as the maximum value, where 0 indicate no activity and 10 indicate independent walking.
Measured: ICU admission up to 6 months
Weight
Weight, Changes in weight between measurement points
Measured: Baseline, day 10, day 30, day 90 and day 180
Physical performance
Changes in physical performance will be assessed using the Short Physical Performance Battery (SPPB). It consists of three tests; gait speed, balance test and a sit-to-stand test. The scores of the three tests are summarized, and the total score is ranging from 0 points to a maximum of 12 points. The score is divided in three levels of performance: low (0-6 points), medium (7-9 points), and high (10-12 points)
Measured: Day 10, day 30, day 90 and day 180
Hand grip strength
Changes in hand grip strength assessed with a hand dynamometer
Measured: Day 10, day 30, day 90 and day 180
Body composition
Changes in fat-free mass and lean mass assessed with bioelectrical impedance analysis (BIA).
Measured: Day 10, day 30, day 90 and day 180
Muscle mass
Changes in muscle mass assessed with ultrasound
Measured: Baseline, day 10, day 30, day 90 and day 180
Resting energy expenditure
Changes in resting energy expenditure measured with indirect calorimetry
Measured: Day 10, day 30, day 90 and day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 2 arms
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Northern Norway Health Authority, Karolinska University Hospital
- Responsible party
- Principal investigator, Anders Benjamin Kildal, University Hospital of North Norway
- Investigators
- Anders Benjamin Kildal, MD, PHD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149246
- Sponsor's protocol ID
- 2025/882796 (REK)
- Other IDs
- HNF1745-25, 2025
- Acronym
- DETAIL
- Status last verified
- Sep 2025
- First submitted
- 5 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to patient confidentiality. Parts of the data set may be available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a 6-month DiEtitian-TAILored Nutrition Intervention Compared to Usual Care in Patients With Critical Illness. A Single Center Prospective Intervention Study
- ClinicalTrials.gov ID
- NCT07149246
- Acronym / sponsor ID
- DETAIL / 2025/882796 (REK)
- Conditions
- ICU Patients, Nutrition Intake, Critical Illness
- Keywords
- Nutrition, Energy intake, Protein intake, ICU, Dietitian
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Northern Norway Health Authority, Karolinska University Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 29 Aug 2025 (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.
This research project aims to study the effect of optimal and individualised nutrition to patients with critical illness during the intensive care unit (ICU) and hospital admission, and until six months after admission. The investigators want to describe and compare the usual care with a dietitian-tailored nutrition care. The hypothesis is that dietitian-tailored nutrition care will result in a higher mean energy intake compared to usual care.
Detailed description
The study will recruit patients with critical illness in one of two groups. Group one will receive standard nutrition care following the current local guidelines. Group two will receive frequent follow-up by a clinical dietitian from inclusion and until six months from admission. The dietitian will be responsible for the nutrition administered to the patient during hospital admission and will have consultations with the patients after discharge. The patients in group two will receive individualized nutrition care and recommendations.
In addition to outcome measures regarding nutrition, the patients can choose if they want to perform physical tests and blood tests as well, but that part of the study is optional. In both groups, outcome measures will be collected at day ten, 30, 90 and 180 days after admission to the ICU. The collection of data will occur even though the patients have been discharged from the hospital, either to their home or another health care facility.
The aim is to study the effect of optimal and individualised nutrition to patients with critical illness during the ICU and hospital admission, and until six months after admission. Firstly, the investigators want to describe the usual care and progression of the patients during the first six months after hospital admission. Secondly, the investigators want to see if frequent follow-up by a clinical dietitian can increase nutritional intake during the same period.
The hypothesis is that dietitian-tailored nutrition care will result in a higher mean energy intake compared to usual care, and that this will further impact other aspects, such as quality of life and physical function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | – |
| Nutrition intervention | Experimental | Other: Nutrition interventionA 6-month Dietitian-tailored nutrition intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Death is imminent in the next 96 hours or there is a current treatment limitation in place or the patient is unlikely to survive to 180 days due to underlying/chronic illness
- Dialysis dependent chronic renal failure
- Suspected or known pregnancy
- Wheelchair user
- Cognitive impairment in which intervention is considered not appropriate
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 |
|---|---|---|
| Nutrition interventionFrequent follow-up from a dietitian during ICU and hospital stay, and after discharge, up to 6 months after ICU admission. | Other | Nutrition intervention |
Primary outcome
Mean energy intake
Time frame: Up to 6 months
Mean energy intake from day 10 to the end of follow-up of 6 months.
14 secondary outcomes
Protein intake
Time frame: Up to 6 months
Nutrition intake
Time frame: Day 10, day 30, day 90 and day 180
Nutrition risk during overall follow-up
Time frame: Baseline, day 10, day 30, day 90 and day 180
Nutrition risk during ICU admission
Time frame: ICU admission up to 6 months
Health related quality of life
Time frame: Day 10, day 30, day 90 and day 180
Self-rated health state
Time frame: Day 10, day 30, day 90 and day 180
Frailty
Time frame: Baseline, day 10, day 30, day 90 and day 180
Mobility
Time frame: ICU admission up to 6 months
Weight
Time frame: Baseline, day 10, day 30, day 90 and day 180
Physical performance
Time frame: Day 10, day 30, day 90 and day 180
Hand grip strength
Time frame: Day 10, day 30, day 90 and day 180
Body composition
Time frame: Day 10, day 30, day 90 and day 180
Muscle mass
Time frame: Baseline, day 10, day 30, day 90 and day 180
Resting energy expenditure
Time frame: Day 10, day 30, day 90 and day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to patient confidentiality. Parts of the data set may be available on reasonable request.
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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.
Anders Benjamin Kildal, MD, PHD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition intervention in people with ICU Patients and Nutrition Intake, run by University Hospital of North Norway at 1 site in Norway.
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 0 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Benjamin Kildal, MD, PHD (+47 77798928, anders.benjamin.kildal@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean energy intake (time frame: Up to 6 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 3 Sep 2025.