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Diet Induced Ketosis for Brain Injury - A Feasibility Study

NCT04308577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-07-15

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Ketogenic diet with added MCT

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%.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Jens Rikardt Andersen

    lead OTHER

Principal Investigators

  • Maria Edwards, Student · University of Copenhagen

  • Jens R Andersen, MD,MPA · University of Copenhagen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2021-02-09
Completion
2021-05-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308577 on ClinicalTrials.gov