Clinical trial NCT03202108: Evaluation of Krio in Children and Adults With Epilepsy
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ketogenic Dieting
Epilepsy
Glucose Transporter Type 1 Deficiency Syndrome
Keywords: Ketogenic
Diet
Epilepsy
Glut-1 DS
Krio
Lead sponsor: Vitaflo International, Ltd
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Product compliance daily diary
timeFrame: Days 1-7
measure: GI tolerance daily diary
timeFrame: Days 1-7
measure: Ease of use questionnaire
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Rachel Meskell
role: PRINCIPAL_INVESTIGATOR
References: