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Evaluation of Krio in Children and Adults With Epilepsy (Krio)

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ClinicalTrials.gov Identifier: NCT03202108
Recruitment Status : Withdrawn (Product manufacturing issues.)
First Posted : June 28, 2017
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Vitaflo International, Ltd

Brief Summary:
Acceptability study to evaluate the gastrointestinal tolerance, palatability and participant compliance, over a 7-day period, of Krio for the dietary management of participants with intractable epilepsy or Glut-1 deficiency syndrome patients on a ketogenic diet.

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

Detailed Description:

This is a prospective, acceptability study in fifteen (15) participants aged three (3) years and over, who are established on a ketogenic diet (KD), of Krio to aid in the management of their diet.

Participants will be provided with a 7-day supply of Krio and will be asked to complete a daily diary and short questionnaire to record information allowing assessment the following:

  • Gastrointestinal tolerance
  • Palatability
  • Compliance

Krio 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, medium chain triglyceride (MCT), modified Atkins diet (MAD) and low glycaemic index (LGI). It is suitable from 3 years of age.

Krio is presented as a ready to eat solid bar (28g), with no additional preparation required. It contains fat (20g per bar), protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients.

The recommended intake of the product for each participant will be determined by a dietitian. The quantity to be consumed daily will be recommended on an individual patient basis, but will be a minimum of 1 bar.

Product acceptability data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the Acceptability of Krio, a Food for Special Medical Purposes (FSMP) for Use in the Ketogenic Diet (KD) With Regard to Product Tolerance, Compliance and Acceptability
Actual Study Start Date : May 11, 2018
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 28, 2018


Arm Intervention/treatment
Experimental: Consumption of Krio
Incorporation of Krio into the daily diet.
Dietary Supplement: Krio

Krio is a ready to eat, chocolate-flavoured, solid bar containing 20g fat per 28g bar. It contains protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients. Krio is not for use as a sole source of nutrition.

It has a fat to protein and carbohydrate ratio of 3 to 1, making it suitable for use in all versions of the ketogenic diet.

This product is to be consumed daily under the direction of a dietitian.





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

  2. 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.

  3. Ease of use questionnaire [ Time Frame: Day 8 ]
    Qualitative assessment from subject questionnaire that allows evaluation of the ease of use of the study product.



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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:

i) Confirmed diagnosis of a condition requiring a KD, e.g. intractable epilepsy, Glut-1 DS.

ii) Aged three (3) years and over.

iii) Currently established on a KD for at least three (3) months, taken orally.

iv) Participant (or parent/guardian) considered by PI and dietitian to be fully proficient at managing the KD, and able to do this competently and accurately.

v) Participant (or parent/guardian) considered by PI and dietitian to be able to follow the protocol requirements and complete the diary and questionnaire.

vi) Freely given, written, informed consent from patient or parent/guardian.

vii) Freely given, written assent (if appropriate).

Exclusion Criteria:

i) Inability to comply with the study protocol, in the opinion of the investigator.

ii) Inability to comply with the ketogenic diet.

iii) Women who are pregnant / breastfeeding at the start of the study or planning to become pregnant during the study period.

N.B.: Women who become pregnant unexpectedly during this study may, in consultation with their doctor, continue on the study's dietary product if they wish but will not have any investigations that would not normally be carried out during pregnancy.


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): NCT03202108


Sponsors and Collaborators
Vitaflo International, Ltd
Investigators
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Principal Investigator: Rachel Meskell Leeds Teaching Hospitals NHS Trust
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Responsible Party: Vitaflo International, Ltd
ClinicalTrials.gov Identifier: NCT03202108    
Other Study ID Numbers: MCT-KRIO-2015-01-06
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vitaflo International, Ltd:
Ketogenic
Diet
Epilepsy
Glut-1 DS
Krio
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases