NCT03196271

Ketogenic Diet Drink Study

Evaluating the Tolerance, Compliance, Acceptability and Safety of Ketocal 2.5:1 LQ, 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Nutricia UK Ltd · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Intractable Epilepsy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketocal 2.5:1	A ketogenic feed for the dietary management of intractable epilepsy is given over a period of four weeks, after a control period of 4 weeks. The amount of the feed given is determined by the Dietitian and/or Doctor responsible for the patient's care (at least one carton per day).

Timeline

• Start date: 2017-01-04
• Primary completion: 2018-12-10
• Completion: 2018-12-10
• First posted: 2017-06-22
• Last updated: 2019-07-08

Locations

9 sites across 1 country: United Kingdom