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Ketogenic Diet Drink Study

Primary Purpose

Intractable Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ketocal 2.5:1
Sponsored by
Nutricia UK Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Intractable Epilepsy

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • North Bristol NHS Trust
  • University Hospitals Southampton NHS Foundation Trust
  • NHS Grampian
  • Birmingham and Solihull Mental Health NHS Foundation Trust
  • Birmingham Women's and Children's NHS Foundation Trust
  • University Hospitals Bristol NHS Foundation Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • NHS Tayside
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Gastrointestinal tolerance
GI tolerance will be recorded throughout the study via standardised questionaire

Secondary Outcome Measures

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.
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.
Adverse events and Seizures
All adverse events and seizures will be monitored throughout the study.
Nutrient intake
Food diaries and 24hr recalls during baseline, control and intervention periods
Height
Height (cm)
Weight
Weight (kg)
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

Full Information

First Posted
May 26, 2017
Last Updated
July 5, 2019
Sponsor
Nutricia UK Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03196271
Brief Title
Ketogenic Diet Drink Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia UK Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Epilepsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Other
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Ketocal 2.5:1
Intervention Description
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).
Primary Outcome Measure Information:
Title
Gastrointestinal tolerance
Description
GI tolerance will be recorded throughout the study via standardised questionaire
Time Frame
Throughout study (59 days)
Secondary Outcome Measure Information:
Title
Compliance with feed prescription
Description
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)
Title
Acceptability and Ease of Use
Description
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)
Title
Adverse events and Seizures
Description
All adverse events and seizures will be monitored throughout the study.
Time Frame
Throughout study (59 days)
Title
Nutrient intake
Description
Food diaries and 24hr recalls during baseline, control and intervention periods
Time Frame
Throughout study (59 days)
Title
Height
Description
Height (cm)
Time Frame
59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Title
Weight
Description
Weight (kg)
Time Frame
59 days (measured at start (day 1), middle (day 31) and end of this period (day 59))
Title
Ketone levels
Description
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
Time Frame
59 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Stratton, PhD
Organizational Affiliation
Nutricia, University of Southampton.
Official's Role
Study Director
Facility Information:
Facility Name
North Bristol NHS Trust
City
Bristol
State/Province
Bs105nb
Country
United Kingdom
Facility Name
University Hospitals Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
S166YD
Country
United Kingdom
Facility Name
NHS Grampian
City
Aberdeen
ZIP/Postal Code
AB156RE
Country
United Kingdom
Facility Name
Birmingham and Solihull Mental Health NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B13RB
Country
United Kingdom
Facility Name
Birmingham Women's and Children's NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B46NH
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS13NU
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Facility Name
NHS Tayside
City
Dundee
ZIP/Postal Code
DD19SY
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE77DN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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