Market Research - Acceptability Study for a Range of MCT Products

Not Applicable

Completed

• Conditions: Ketosis; Fatty Acid Oxidation Disorder; Epilepsy; Ketogenic Diet; Malabsorption
• Interventions: Dietary Supplement: MCT fats

• Registration Number: NCT04309149
• Lead Sponsor: Dr. Schär AG / SPA

Brief Summary

This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Study First Posted: 2020-03-16
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Diagnosis of epilepsy or a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
• Subjects who are new to or already taking an MCT oil and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between new product trialled.
• Patients aged 3 years of age to adulthood.
• Written informed consent obtained from patient or parental caregiver.

Exclusion Criteria

• Presence of serious concurrent illness
• Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
• Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
• Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
• Patients less than 3 years of age.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MCT fats	MCT fats	Kanso MCT oils and margarine will be consumed daily for 7 days each to assess tolerability and compliance

Primary Outcome Measures

Name	Time	Method
Gastrointestinal tolerance	7 days for each product, maximum 25 days	Questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product
Product compliance	7 days for each product, maximum 25 days	Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Product palatability	7 days for each product, maximum 25 days	Questionnaire data captured to evaluate taste
Product acceptability	7 days for each product, maximum 25 days	Brief tick-box questionnaire on overall liking and acceptability of product

Trial Locations

Locations (2)

Royal Manchester Children's Hospital; 🇬🇧 Manchester, United Kingdom

Bristol Royal Hospital for Children; 🇬🇧 Bristol, United Kingdom