Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke

Last updated: January 6, 2026
Sponsor: University Hospital, Angers
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Treatment

Early nutritional management

Clinical Study ID

NCT07065929
49RC23_0302
2025-A00234-45
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria :

  • 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 adepartment 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 studyor patient included under the emergency procedure in the absence of contactablerelatives

Exclusion

Exclusion Criteria:

  • Patients treated with nutritional therapy at the time of admission (history ofbariatric 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

  • Patient deprived of liberty by judicial or administrative decision

  • Patient under compulsory psychiatric care

  • Person under legal protection

  • Poor understanding of the French language

Study Design

Total Participants: 3084
Treatment Group(s): 1
Primary Treatment: Early nutritional management
Phase:
Study Start date:
September 19, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • CH Versailles

    Chesnay, Yvelines 78150
    France

    Site Not Available

  • CH Versailles

    Chesnay 3025405, Yvelines 78150
    France

    Active - Recruiting

  • CHU Angers

    Angers, 49933
    France

    Site Not Available

  • CHU Angers

    Angers 3037656, 49933
    France

    Active - Recruiting

  • CHU Caen

    Caen, 14033
    France

    Site Not Available

  • CHU Caen

    Caen 3029241, 14033
    France

    Active - Recruiting

  • CH Cholet

    Cholet, 49300
    France

    Site Not Available

  • CH Cholet

    Cholet 3025053, 49300
    France

    Active - Recruiting

  • CHD La Roche sur Yon

    La Roche sur Yon, 85925
    France

    Site Not Available

  • CHD La Roche sur Yon

    La Roche-sur-Yon 3006767, 85925
    France

    Site Not Available

  • CH La Rochelle

    La Rochelle, 17000
    France

    Site Not Available

  • CH La Rochelle

    La Rochelle 3006787, 17000
    France

    Active - Recruiting

  • CH Chartres

    Le Coudray, 28630
    France

    Site Not Available

  • CH Chartres

    Le Coudray 3004471, 28630
    France

    Active - Recruiting

  • CHU Rouen

    Rouen, 76000
    France

    Site Not Available

  • CHU Rouen

    Rouen 2982652, 76000
    France

    Active - Recruiting

  • CHU Nantes

    Saint Herblain, 44800
    France

    Site Not Available

  • CH St Malo

    Saint Malo, 35043
    France

    Site Not Available

  • CHU Nantes

    Saint-Herblain 2979590, 44800
    France

    Site Not Available

  • CH St Malo

    St-Malo 2978640, 35043
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse, 31059
    France

    Site Not Available

  • CHU Toulouse

    Toulouse 2972315, 31059
    France

    Site Not Available

  • CHU Tours

    Tours, 37000
    France

    Site Not Available

  • CHU Tours

    Tours 2972191, 37000
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.