Evaluation of Krio in Children and Adults With Epilepsy

NCT03202108 | Withdrawn

• 1 other identifier: MCT-KRIO-2015-01-06
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ketogenic Dieting; Epilepsy; Glucose Transporter Type 1 Deficiency Syndrome

Keywords

Ketogenic; Diet; Epilepsy; Glut-1 DS; Krio

Outcome Measures

Primary Outcomes (3)

• Product compliance daily diary

  Quantitative assessments from subject questionnaires that allow evaluation of compliance with the study product, i.e. actual versus prescribed intake.

  Days 1-7

• GI tolerance daily diary

  Qualitative assessments from subject questionnaires that allow evaluation of the gastro-intestinal tolerance of the study product.

  Days 1-7

• Ease of use questionnaire

  Qualitative assessment from subject questionnaire that allows evaluation of the ease of use of the study product.

  Day 8

Study Arms (1)

Consumption of Krio

EXPERIMENTAL

Incorporation of Krio into the daily diet.

Dietary Supplement: Krio

Interventions

Krio DIETARY_SUPPLEMENT

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.

Consumption of Krio

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitaflo International, Ltd: lead

MeSH Terms

Conditions

Epilepsy; Glut1 Deficiency Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rachel Meskell

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: May 11, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 28, 2018
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share