Ketogenic Diet Drink Study

N/ACompletedNCT03196271

Nutricia UK Ltd26 enrolled

Overview

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Intractable Epilepsy

Interventions

Ketocal 2.5:1DIETARY_SUPPLEMENT

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).

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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)

Locations (9)

North Bristol NHS Trust

Bristol, Bs105nb, United Kingdom

University Hospitals Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

NHS Grampian

Aberdeen, United Kingdom

Outcomes

Primary Outcomes

Gastrointestinal tolerance

GI tolerance will be recorded throughout the study via standardised questionaire

Time frame: Throughout study (59 days)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Throughout study (59 days)

Nutrient intake

Food diaries and 24hr recalls during baseline, control and intervention periods

Time frame: Throughout study (59 days)

Height

Height (cm)

Time frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))

Weight

Weight (kg)

Time frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))

Data from ClinicalTrials.gov

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