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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nutricia UK Ltd
- Enrollment
- 26
- Locations
- 9
- Primary Endpoint
- Gastrointestinal tolerance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Study arm
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.
Intervention: Ketocal 2.5:1 (Dietary Supplement)
Outcomes
Primary Outcomes
Gastrointestinal tolerance
Time Frame: Throughout study (59 days)
GI tolerance will be recorded throughout the study via standardised questionaire
Secondary Outcomes
- 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))
- Compliance with feed prescription(Throughout intervention period (28 days))
- Nutrient intake(Throughout study (59 days))
- Adverse events and Seizures(Throughout study (59 days))
- Height(59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)))
- Weight(59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)))
- Ketone levels(59 days.)