NCT04308577

Brief Summary

Each year, approx. 100 patients with severe brain injury is admitted to the Clinic for Neurorehabilitation/TBI Unit, Rigshospitalet. Severe brain injury results in local oxygen deficiency and acid formation in the brain, which together destroys brain cells. The purpose of this study is to investigate whether it is possible to carry out a ketogenic diet therapy for patients with severe brain injury for six weeks. Ketosis has been shown to be neuroprotective during and after severe brain injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

March 6, 2020

Last Update Submit

July 9, 2021

Conditions

Brain InjuriesTraumatic Brain InjurySubarachnoid HemorrhageStrokeAnoxic Brain InjuryNeuroinfections

Outcome Measures

Primary Outcomes (3)

  • Can the intervention be completed during 6 weeks hospitalization

    Yes/No, % of patients with intended b-BHB (b-BHB ≥ 0,5 mmol/L) in % of intervention days

    6 weeks

  • The occurrence of adverse reactions related to the ketogenic treatment, specified

    % of days with adverse effects during intervention

    6 weeks

  • Can patients accept the treatment

    Yes/No, % of intervention days

    6 weeks

Secondary Outcomes (5)

  • Change in Glasgow Coma Scale (GCS)

    6 weeks

  • Change in Early Functional Abilities (EFA)

    6 weeks

  • Change in Functional Independence Measure (FIM)

    6 weeks

  • Change in Functional Oral Intake Scale (FOIS)

    6 weeks

  • Change in Ranchos Los Amigos Scale (RLAS)

    6 weeks

Study Arms (1)

Ketogenic diet with MCT

EXPERIMENTAL

Ketogenic Diet supplemented with MCT everyday for 6 weeks.

Other: Ketogenic diet with added MCT

Interventions

Ketogenic diet with added MCTOTHER

The intervention is a ketogenic diet consisting of KetoCal 2,5:1 LQ MCT Multi Fibre (Nutricia), Liquigen (MCT)(Nutricia) and ketogenic meals provided by the hospital kitchen. The macronutrient composition of the ketogenic diet given approx.: Protein 11 E%, Carbohydrate 3 E%, Fat 86 E%.

Ketogenic diet with MCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with severe acquired brain injury (TBI, stroke, SAH, anoxic brain injury or neuroinfection)
  • Patients ≥ 18 years
  • Understand and speak Scandinavian language
  • Informed consent from patient or deputy consent if the patient is unable to give consent due to reduced state of consciousness
  • Expectation of prolonged hospitalization

You may not qualify if:

  • Contraindication to a ketogenic diet
  • Dysregulated Diabetes Mellitus
  • Medicated for elevated triglycerides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Neurorehabilitation / TBI Unit, Rigshospitalet (Satellite Department on Hvidovre Hospital)

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Edwards MGP, Andersen JR, Curtis DJ, Riberholt CG, Poulsen I. Diet-induced ketosis in adult patients with subacute acquired brain injury: a feasibility study. Front Med (Lausanne). 2024 Mar 19;10:1305888. doi: 10.3389/fmed.2023.1305888. eCollection 2023.

    PMID: 38571572DERIVED

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, TraumaticSubarachnoid HemorrhageStrokeHypoxia-Ischemia, Brain

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBrain IschemiaHypoxia, BrainHypoxiaSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Maria Edwards, Student

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Jens R Andersen, MD,MPA

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 16, 2020

Study Start

October 5, 2020

Primary Completion

February 9, 2021

Study Completion

May 31, 2021

Last Updated

July 15, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)