Market Research - Acceptability Study for a Range of MCT Products

Dr. Schär

Status

Completed

Conditions

Epilepsy

Ketosis

Malabsorption

Ketogenic Diet

Fatty Acid Oxidation Disorder

Treatments

Dietary Supplement: MCT fats

Study type

Interventional

Funder types

Industry

Identifiers

NCT04309149

Kanso 1

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

2 to 60 years old

Volunteers

No Healthy Volunteers

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.