Clinical trial NCT03196271: Ketogenic Diet Drink Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intractable Epilepsy
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2017-06-22
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 8 years of age or older
* Diagnosed with intractable epilepsy or another disorder where the KD is indicated
* Motivated to follow the KD for at least the duration of the trial period
* Either currently on a KD, or referred to start a KD
* Likely to benefit from Ketocal 2.5:1
* Written informed consent from patient and/or parent/carer, or completed consultee declaration form
* Willing to take finger prick blood samples to measure ketone levels

Exclusion Criteria:

* Being pregnant or planning pregnancy
* Requiring parenteral nutrition
* Major hepatic or renal dysfunction
* Participation in other clinical intervention studies within 1 month prior to entry of this study
* Allergy to any of the study product ingredients
* Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements
* Any contraindications for the use of the ketogenic diet
* Significantly underweight (Body Mass Index \<18.5)

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: Throughout study (59 days)
Secondary outcomes:
measure: Compliance with feed prescription
timeFrame: Throughout intervention period (28 days)
measure: Acceptability and Ease of Use
timeFrame: Measured on day 28 to represent 4 week baseline period, and also measured on day 59 (reflecting 4 week intervention period)
measure: Adverse events and Seizures
timeFrame: Throughout study (59 days)
measure: Nutrient intake
timeFrame: Throughout study (59 days)
measure: Height
timeFrame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
measure: Weight
timeFrame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
measure: Ketone levels
timeFrame: 59 days.
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
state: Bs105nb
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton NHS Foundation Trust
state: Hampshire
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: Birmingham
country: United Kingdom
facility: Birmingham and Solihull Mental Health NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
affiliation: Nutricia, University of Southampton.
name: Rebecca Stratton, PhD
role: STUDY_DIRECTOR
References: