Market Research - Acceptability Study for New MCT Fat Products

Dr. Schär

Status: Completed

Conditions: Epilepsy; Ketosis; Ketogenic Diet; Malabsorption; Fatty Acid Oxidation Disorder; Medium Chain Triglycerides

Treatments: Dietary Supplement: MCT fats

Study type: Interventional

Funder types: Industry

Identifiers

NCT04309214

Kanso 2

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 3 to 20 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

MCT fats

Experimental group

Description:

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.

Treatment:

Dietary Supplement: MCT fats