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Evaluation of Keyo in Children With Epilepsy (Keyo)

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: NCT02915211
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Vitaflo International, Ltd

Brief Summary:
To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.

Condition or disease Intervention/treatment Phase
Intractable Epilepsy Glucose Transporter Type 1 Deficiency Syndrome Ketogenic Dieting Dietary Supplement: Keyo Not Applicable

Detailed Description:

Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.

Collection of daily data about the gastro-intestinal tolerance of the study product.

Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.

Improve quality of life by increasing range of foods available for use in a ketogenic diet.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the Acceptability of Keyo, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: Consumption of Keyo
Participants will consume their normal KD and take Keyo as advised by the lead dietitian.
Dietary Supplement: Keyo
Keyo is a Food for Special Medical Purposes (FSMP) and is intended for use in the KD. It has a fat to protein and carbohydrate ratio of 3 to 1. This makes it appropriate for inclusion in all versions of the KD - classical, MCT, MAD and LGI. Keyo has been designed as a nutritionally complete, ready to use, pleasant tasting and versatile medical food for use in a KD.




Primary Outcome Measures :
  1. Palatability questionnaire [ Time Frame: Day 8 ]
    Qualitative assessment from subject questionnaire that allows evaluation of the palatability of the study product.

  2. Ease of use daily diary [ Time Frame: Days 1-7 ]
    Qualitative assessments from subject questionnaires that allow evaluation of the ease of use of the study product.

  3. GI tolerance daily diary [ Time Frame: Days 1-7 ]
    Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.

  4. Product compliance daily diary [ Time Frame: Days 1-7 ]
    Qualitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 years and over
  • Confirmed diagnosis of intractable epilepsy or Glut-1 DS
  • Children must be currently established on a KD for at least 3 months, taken orally
  • Written, informed consent by participant/carer

Exclusion Criteria:

-


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): NCT02915211


Locations
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United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Sponsors and Collaborators
Vitaflo International, Ltd
Investigators
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Principal Investigator: Helen McCullagh, BSc, MBChB Leeds Teaching Hospitals NHS Trust

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Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT02915211    
Other Study ID Numbers: MCT-Keyo-11/12/15-01
196542 ( Other Identifier: IRAS )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Vitaflo International, Ltd:
Epilepsy
Glut
Ketogenic
Glucose
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases