Ketogenic Diet Drink Study

Intractable Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196271
• Other study ID #: K251 Study
• Status: Completed
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: July 2019
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 10, 2018
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Intractable Epilepsy

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen
United Kingdom	Birmingham and Solihull Mental Health NHS Foundation Trust	Birmingham
United Kingdom	Birmingham Women's and Children's NHS Foundation Trust	Birmingham
United Kingdom	North Bristol NHS Trust	Bristol	Bs105nb
United Kingdom	University Hospitals Bristol NHS Foundation Trust	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	NHS Tayside	Dundee
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	University Hospitals Southampton NHS Foundation Trust	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal tolerance	GI tolerance will be recorded throughout the study via standardised questionaire	Throughout study (59 days)
Secondary	Compliance with feed prescription	Compliance with the study product will be assessed daily throughout the study intervention period by recording how much feed was consumed in mls and comparing this to the amount patients have been prescribed by their Dietitian.	Throughout intervention period (28 days)
Secondary	Acceptability and Ease of Use	Acceptability and ease of use will be assessed by questionnaire completed by the parent/carer at the end of the control period (Day 28) for the KD, and at the end of the intervention period (Day 56) for both the diet as a whole and the study product alone.	Measured on day 28 to represent 4 week baseline period, and also measured on day 59 (reflecting 4 week intervention period)
Secondary	Adverse events and Seizures	All adverse events and seizures will be monitored throughout the study.	Throughout study (59 days)
Secondary	Nutrient intake	Food diaries and 24hr recalls during baseline, control and intervention periods	Throughout study (59 days)
Secondary	Height	Height (cm)	59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Secondary	Weight	Weight (kg)	59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Secondary	Ketone levels	Blood ketone levels captured via fingerprick blood test 9 days (3 in baseline, 3 in control period and 3 day in the intervention period), twice a day. All other ketone levels alo recorded	59 days.