Ketogenic Diet Drink Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Intractable Epilepsy

Intervention / Treatment
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* Dietary Supplement: Ketocal 2.5:1


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study arm<br>One single arm, consisting of a 3 day baseline period, a 28 day control period and a 28 day intervention period (Ketocal 2.5:1), in that order. | Dietary Supplement: Ketocal 2.5:1<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | GI tolerance will be recorded throughout the study via standardised questionaire | Throughout study (59 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| Adverse events and Seizures | All adverse events and seizures will be monitored throughout the study. | Throughout study (59 days) | 
| Nutrient intake | Food diaries and 24hr recalls during baseline, control and intervention periods | Throughout study (59 days) | 
| Height | Height (cm) | 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) | 
| Weight | Weight (kg) | 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) | 
| 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. |