Acute StrokeAVC-NUT2NCT07065929
Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke
A study testing Early nutritional management in people with Acute Stroke, run by University Hospital, Angers at 12 sites in France.
Trial summary
This study evaluate the impact of early personalized nutritional management on 1-month mortality after acute stroke. In the randomised centres of the interventional group (early personalized nutritional management), each patient will be assessed by a dietician within 2 days of stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Early nutritional management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,084 participants
- Where
- 12 sitesFrance
- Study dates
- 19 Sep 2025to Dec 2027
- 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
- Patients ≥ 18 years of age
- With an acute, ischaemic or haemorrhagic outpatient or inpatient stroke
- NIHSS score ≥ 5
- Hospitalised in a neurology department, or Neuro Vascular Unit (NVU), or in a department where beds are dedicated to receiving post-stroke patients
- Stroke less than 2 days old
- Anticipated length of hospital stay in a participating centre ≥ 5 days
- Patient affiliated to or benefiting from a social security scheme
- Patient or close relative having given written consent to participate in the study or patient included under the emergency procedure in the absence of contactable relatives or patients enrolled under the emergency protocol when no family members were present within 2 days of the stroke.
Who cannot join
- Patients treated with nutritional therapy at the time of admission (history of bariatric surgery or gastrectomy, malabsorptive pathologies such as short bowel, extensive intestinal resections, etc.).
- In a palliative situation where life expectancy is < 3 months
- Patient taking part in another study with an impact on mortality or nutrition
- Previous inclusion in the trial
- Pregnant, breast-feeding or parturient woman
- Patient unable to follow the protocol for any reason
Show all 10Show fewer
- Patient deprived of liberty by judicial or administrative decision
- Patient under compulsory psychiatric care
- Person under legal protection
- Poor understanding of the French language
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
CHU Angers
Angers, 49933
Angélique CAMPION, 0241353637 ext. +33, angelique.campion@chu-angers.fr
- Recruiting
CHU Caen
Caen, 14033
Agathe DELEAND, 02 31 06 39 21 ext. +33, deleand-a@chu-caen.fr
- Recruiting
CH Versailles
Chesnay, Yvelines, 78150
Lucie SEBLIN, 01 39 63 89 69 ext. +33, lgiboulot@ght78sud.fr
- Recruiting
CH Cholet
Cholet, 49300
Mathilde POUPIN, 02 41 49 62 89 ext. +33, dietetique@ch-cholet.fr
- Recruiting
CHD La Roche sur Yon
La Roche-sur-Yon, 85925
Elie GUYAU, 02 51 44 61 61 ext. +33, elie.guyau@ght85.fr
- Recruiting
CH La Rochelle
La Rochelle, 17000
Charlotte VINCENT, 05 46 45 67 62 ext. +33, charlotte.vincent@ght-atlantique17.fr
- Recruiting
CH Chartres
Le Coudray, 28630
Véronique LUCAS, 02 37 30 36 28, dietft@ch-chartres.fr
- Recruiting
CHU Rouen
Rouen, 76000
Siriane LANDRY, 02 32 88 89 90 ext. +33, siriane.Landry@chu-rouen.fr
- Not yet recruiting
CHU Nantes
Saint-Herblain, 44800
Audrey FELTRI, 02 44 76 84 95 ext. +33, audrey.feltri@chu-nantes.fr
- Recruiting
CH St Malo
St-Malo, 35043
Charline BARBE, 02 99 21 20 78, c.barbe@ch-stmalo.fr
- Recruiting
CHU Toulouse
Toulouse, 31059
Jérémy GEFFROY, 05 61 77 55 69 ext. +33, geffroyjeremy@gmail.com
- Recruiting
CHU Tours
Tours, 37000
Pauline CHEVE, 02 47 47 47 47 ext. +33, p.cheve@chu-tours.fr
About this study
Official title: Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke Pragmatic, Controlled, Multicenter, Cluster-randomized Trial
This study evaluate the impact of early personalized nutritional management on 1-month mortality after acute stroke.
In the randomised centres of the interventional group (early personalized nutritional management), each patient will be assessed by a dietician within 2 days of stroke. Any swallowing problems are screened, and any barriers to eating are identified before dietary support. Patient's food intakes are recorded until the 7th day post-acute to assess their energy intake. Depending on patient's nutritional objectives, a reinforced feeding strategy comprising 2 levels is put in place, in order to prevent malnutrition: in level 1, the dietician tries to meet nutritional requirements orally, while in level 2 he can recourse to artificial nutrition in the event of failure or inability to meet requirements with oral intake alone. This strategy is started immediately after the initial assessment. Intakes are reassessed every 24 to 48 hours by the dietician in order to adapt the nutritional strategy as quickly as possible in order to cover the patient's personnalized nutritional needs.
Read more
No change in practice was required of the randomised centres in the control group.
All patients will be contacted by telephone 30 days after stroke to collect parts of the assessment criteria, while the other criteria will be collected directly from the patient's computerised medical record.
Three months after stroke, an evaluation of quality of life and modified Rankin test will be performed.
Our hypothesis is that the implementation of an individualized management of early nutritional support, aimed at compensating for the decrease in intake associated with the disease, would reduce mortality at 30 days in patients hospitalised for stroke.
- Conditions
- Acute Stroke
- Being tested
- Early nutritional management
- Keywords
- acute stroke, early nutrition, personalized dietary support
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early nutritional managementDietary supplement
The food ingested by patients is collected until the day 7 of the stroke so that dieticians can calculate their needs and provide a suitable diet. If this is not sufficient, a reinforced nutrition strategy (meal enrichment) is implemented.
On day 5 of the stroke, if energy intake is less than 2/3 of the energy objectives, the strategy is switched to level 2, unless it is possible to increase intake within 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | early nutritional management Receives: Dietary Supplement: Early nutritional management |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality at 30 days after stroke (main criterion)
Recording patient status at 30 days after stroke
Measured: At 30 days of the day of the stroke
Secondary outcomes (8)
Proportion of patients with modified Rankin score ≤ 2, 3 months after stroke
Modified Rankin score is evaluated at 3 months after stroke and a percentage of patients with a score < 2 will be calculated
Measured: At 90 days of the day of the stroke
Nutritional status at 30 days defined by BMI, weight change over 30 days and albumin rate, used to classify patients as severely undernourished, moderately undernourished or not undernourished.
Measured: At 30 days of the day of the stroke
Time to occurrence of inhalation pneumonia related to the presence of a feeding tube recorded within 30 days of the day of the stroke
Recording of inhalation pneumonia related to the presence of a feeding tube
Measured: Within 30 days of the day of the stroke
Time to occurrence of infection related to a catheter dedicated to parenteral nutrition recorded within 30 days of the day of the stroke
Recording of infection related to a catheter dedicated to parenteral nutrition
Measured: Within 30 days of the day of the stroke
Time to occurrence of death recorded within 30 days of the day of the stroke:
Recording of death
Measured: Within 30 days of the day of the stroke
Hospital stay (in days) with censoring at 3 months after stroke
Calculation of the number of days of hospitalisation between the stoke and the date of discharge from the Department
Measured: Length of hospitalization (in days), calculated between the stroke 's date (day 0) and the date of discharge from the Neurology Department, assessed up to 90 days after the stroke.
Evaluation of the variation in the EuroQol 5D quality of life score (EQ-5D-5L) between the pre-stroke period and 3 months after stroke
Estimated quality of life scores before the stroke and at 3 months post-stroke are obtained using EuroQol 5D-5L questionnaires completed with patients or their close relative at 3 month after stroke
Measured: At 90 days of the day of the stroke
Time to occurrence of inhalation pneumonia associated with swallowing disorders recorded within 30 days of the day of the stroke
Recording of inhalation pneumonia associated with swallowing disorders,
Measured: Within 30 days of the day of the stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start19 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomisation in parallel arms
- Masking
- None (open label)
- Enrolment
- 3,084 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Angélique CAMPION, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065929
- Sponsor's protocol ID
- 49RC23_0302
- Other IDs
- 2025-A00234-45
- Acronym
- AVC-NUT2
- Status last verified
- Aug 2026
- First submitted
- 27 May 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke Pragmatic, Controlled, Multicenter, Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT07065929
- Acronym / sponsor ID
- AVC-NUT2 / 49RC23_0302
- Conditions
- Acute Stroke
- Keywords
- acute stroke, early nutrition, personalized dietary support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,084 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jul 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 study evaluate the impact of early personalized nutritional management on 1-month mortality after acute stroke.
In the randomised centres of the interventional group (early personalized nutritional management), each patient will be assessed by a dietician within 2 days of stroke. Any swallowing problems are screened, and any barriers to eating are identified before dietary support. Patient's food intakes are recorded until the 7th day post-acute to assess their energy intake. Depending on patient's nutritional objectives, a reinforced feeding strategy comprising 2 levels is put in place, in order to prevent malnutrition: in level 1, the dietician tries to meet nutritional requirements orally, while in level 2 he can recourse to artificial nutrition in the event of failure or inability to meet requirements with oral intake alone. This strategy is started immediately after the initial assessment. Intakes are reassessed every 24 to 48 hours by the dietician in order to adapt the nutritional strategy as quickly as possible in order to cover the patient's personnalized nutritional needs.
No change in practice was required of the randomised centres in the control group.
All patients will be contacted by telephone 30 days after stroke to collect parts of the assessment criteria, while the other criteria will be collected directly from the patient's computerised medical record.
Three months after stroke, an evaluation of quality of life and modified Rankin test will be performed.
Our hypothesis is that the implementation of an individualized management of early nutritional support, aimed at compensating for the decrease in intake associated with the disease, would reduce mortality at 30 days in patients hospitalised for stroke.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cluster randomisation in parallel arms
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Dietary Supplement: Early nutritional managementearly nutritional management |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years of age
- With an acute, ischaemic or haemorrhagic outpatient or inpatient stroke
- NIHSS score ≥ 5
- Hospitalised in a neurology department, or Neuro Vascular Unit (NVU), or in a department where beds are dedicated to receiving post-stroke patients
- Stroke less than 2 days old
Key exclusion criteria (10 listed)
- Patients treated with nutritional therapy at the time of admission (history of bariatric surgery or gastrectomy, malabsorptive pathologies such as short bowel, extensive intestinal resections, etc.).
- In a palliative situation where life expectancy is < 3 months
- Patient taking part in another study with an impact on mortality or nutrition
- Previous inclusion in the trial
- Pregnant, breast-feeding or parturient woman
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 |
|---|---|---|
| Early nutritional managementThe food ingested by patients is collected until the day 7 of the stroke so that dieticians can calculate their needs and provide a suitable diet. If this is not sufficient, a reinforced nutrition strategy (meal enrichment) is implemented. On day 5 of the stroke, if energy intake is less than 2/3 of the energy objectives, the strategy is switched to level 2, unless it is possible to increase intake within 48 hours. | Dietary supplement | Interventional Group |
Primary outcome
mortality at 30 days after stroke (main criterion)
Time frame: At 30 days of the day of the stroke
Recording patient status at 30 days after stroke
8 secondary outcomes
Proportion of patients with modified Rankin score ≤ 2, 3 months after stroke
Time frame: At 90 days of the day of the stroke
Nutritional status at 30 days defined by BMI, weight change over 30 days and albumin rate, used to classify patients as severely undernourished, moderately undernourished or not undernourished.
Time frame: At 30 days of the day of the stroke
Time to occurrence of inhalation pneumonia related to the presence of a feeding tube recorded within 30 days of the day of the stroke
Time frame: Within 30 days of the day of the stroke
Time to occurrence of infection related to a catheter dedicated to parenteral nutrition recorded within 30 days of the day of the stroke
Time frame: Within 30 days of the day of the stroke
Time to occurrence of death recorded within 30 days of the day of the stroke:
Time frame: Within 30 days of the day of the stroke
Hospital stay (in days) with censoring at 3 months after stroke
Time frame: Length of hospitalization (in days), calculated between the stroke 's date (day 0) and the date of discharge from the Neurology Department, assessed up to 90 days after the stroke.
Evaluation of the variation in the EuroQol 5D quality of life score (EQ-5D-5L) between the pre-stroke period and 3 months after stroke
Time frame: At 90 days of the day of the stroke
Time to occurrence of inhalation pneumonia associated with swallowing disorders recorded within 30 days of the day of the stroke
Time frame: Within 30 days of the day of the stroke
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 1 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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.
Angélique CAMPION principal investigator
University Hospital, Angers
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early nutritional management in people with Acute Stroke, run by University Hospital, Angers at 12 sites in France.
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 8 inclusion and 10 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 1 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 12 sites in France. 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 Angélique CAMPION (02 41 35 36 37 ext. +33, Angelique.Campion@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality at 30 days after stroke (main criterion) (time frame: At 30 days of the day of the stroke). 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 1 Sep 2026.