Ketogenic Diet Drink Study

Status Completed

Clinical Trial Summary

Clinical Trial Description

An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or other disorders where the KD is indicated.

Study is conducted over 59 days:

3 day baseline period - Patient continues on whatever dietary regimen they were on before joining the study (this may be a ketogenic diet for existing patients).

28 day control period - Patient begins ketogenic diet (if they are not already on one), and continues this for 28 days WITHOUT the study product. Patients already on a ketogenic diet continue this as normal.

28 day intervention period - A set amount of the study product is incorporated into the patient's ketogenic diet.

Data is captured by the HCP in the case report form at baseline, mid study and end of intervention, and by the patient daily throughout in a patient questionnaire. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03196271
Study type	Interventional
Source	Nutricia UK Ltd
Contact
Status	Completed
Phase	N/A
Start date	January 4, 2017
Completion date	December 10, 2018

View Details

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