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Ketogenic Diet Drink Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196271
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Nutricia UK Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intractable Epilepsy Dietary Supplement: Ketocal 2.5:1 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
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.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Gastrointestinal tolerance [ Time Frame: Throughout study (59 days) ]
    GI tolerance will be recorded throughout the study via standardised questionaire


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Adverse events and Seizures [ Time Frame: Throughout study (59 days) ]
    All adverse events and seizures will be monitored throughout the study.

  4. Nutrient intake [ Time Frame: Throughout study (59 days) ]
    Food diaries and 24hr recalls during baseline, control and intervention periods

  5. Height [ Time Frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) ]
    Height (cm)

  6. Weight [ Time Frame: 59 days (measured at start (day 1), middle (day 31) and end of this period (day 59)) ]
    Weight (kg)

  7. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
North Bristol NHS Trust
Bristol, Bs105nb, United Kingdom
University Hospitals Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, S166YD
NHS Grampian
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
NHS Tayside
Dundee, United Kingdom, DD19SY
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE77DN
Sponsors and Collaborators
Nutricia UK Ltd
Investigators
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Study Director: Rebecca Stratton, PhD Nutricia, University of Southampton.
More Information
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Responsible Party: Nutricia UK Ltd
ClinicalTrials.gov Identifier: NCT03196271    
Other Study ID Numbers: K251 Study
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases