Ketogenic Diet Drink Study
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|ClinicalTrials.gov Identifier: NCT03196271|
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intractable Epilepsy||Dietary Supplement: Ketocal 2.5:1||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 4, 2017|
|Actual Primary Completion Date :||December 10, 2018|
|Actual Study Completion Date :||December 10, 2018|
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
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).
- Gastrointestinal tolerance [ Time Frame: Throughout study (59 days) ]GI tolerance will be recorded throughout the study via standardised questionaire
- Compliance with feed prescription [ Time Frame: Throughout intervention period (28 days) ]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.
- Acceptability and Ease of Use [ Time Frame: Measured on day 28 to represent 4 week baseline period, and also measured on day 59 (reflecting 4 week intervention period) ]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.
- Adverse events and Seizures [ Time Frame: Throughout study (59 days) ]All adverse events and seizures will be monitored throughout the study.
- Nutrient intake [ Time Frame: Throughout study (59 days) ]Food diaries and 24hr recalls during baseline, control and intervention periods
- Height [ Time Frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) ]Height (cm)
- Weight [ Time Frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) ]Weight (kg)
- Ketone levels [ Time Frame: 59 days. ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196271
|North Bristol NHS Trust|
|Bristol, Bs105nb, United Kingdom|
|University Hospitals Southampton NHS Foundation Trust|
|Southampton, Hampshire, United Kingdom, S166YD|
|Aberdeen, United Kingdom, AB156RE|
|Birmingham and Solihull Mental Health NHS Foundation Trust|
|Birmingham, United Kingdom, B13RB|
|Birmingham Women's and Children's NHS Foundation Trust|
|Birmingham, United Kingdom, B46NH|
|University Hospitals Bristol NHS Foundation Trust|
|Bristol, United Kingdom, BS13NU|
|Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, United Kingdom|
|Dundee, United Kingdom, DD19SY|
|The Newcastle upon Tyne Hospitals NHS Foundation Trust|
|Newcastle upon Tyne, United Kingdom, NE77DN|
|Study Director:||Rebecca Stratton, PhD||Nutricia, University of Southampton.|