Ketogenic Diet Drink Study
- Conditions
- Intractable Epilepsy
- Registration Number
- NCT03196271
- Lead Sponsor
- Nutricia UK Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Gastrointestinal tolerance Throughout study (59 days) GI tolerance will be recorded throughout the study via standardised questionaire
- Secondary Outcome Measures
Name Time Method Acceptability and Ease of Use 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.
Compliance with feed prescription 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.
Nutrient intake Throughout study (59 days) Food diaries and 24hr recalls during baseline, control and intervention periods
Adverse events and Seizures Throughout study (59 days) All adverse events and seizures will be monitored throughout the study.
Height 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) Height (cm)
Weight 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) Weight (kg)
Ketone levels 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
Trial Locations
- Locations (9)
North Bristol NHS Trust
🇬🇧Bristol, Bs105nb, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
University Hospitals Bristol NHS Foundation Trust
🇬🇧Bristol, United Kingdom
NHS Tayside
🇬🇧Dundee, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle upon Tyne, United Kingdom
University Hospitals Southampton NHS Foundation Trust
🇬🇧Southampton, Hampshire, United Kingdom
NHS Grampian
🇬🇧Aberdeen, United Kingdom
Birmingham and Solihull Mental Health NHS Foundation Trust
🇬🇧Birmingham, United Kingdom