Market Research - Acceptability Study for New MCT Fat Products

Not Applicable

Completed

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

• Registration Number: NCT04309214
• 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, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Primary Completion: 2019-01-21
• Study Completion: 2019-01-21
• 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 requiring a ketogenic or a specialist diet as part of their treatment.
• Subjects new to taking or who are already taking an MCT product and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between each new product trialled.
• Those patients who have been taking MCT in their diet should do so for a minimum of 4 weeks before commencement of the study.
• 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 already on and MCT product who have been taking it in their diet for less than 4 weeks
• Patients less than 3 years of age
• Patients over 20 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MCT fats	MCT fats	MCT fats to be consumed, one portion per day to ensure tolerance and compliance to the product whilst support the dietary management for a range if disease states namely, the ketogenic diet, fatty acid oxidation disorders and malabsorption.

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 (1)

Royal Aberdeen Children's Hospital; 🇬🇧 Aberdeen, Grampian, United Kingdom