Market Research - Acceptability Study for a Range of MCT Products

Epilepsy Clinical Trial

Official title:

Market Research - Acceptability Study for a Range of New MCT Based Products (Dr Schär - Kanso MCT) Kanso MCT 100% Oil Kanso MCT 77% Oil Kanso MCT 83% Margarine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309149
• Other study ID #: Kanso 1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: Dr. Schär AG / SPA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Fatty Acid Oxidation Disorder
• Ketogenic Diet
• Ketosis
• Malabsorption
• Malabsorption Syndromes

Intervention

Dietary Supplement:
• MCT fats
Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period (21 days taking the new products with 2 days between each new product trialled).

Locations

Country	Name	City	State
United Kingdom	Bristol Royal Hospital for Children	Bristol
United Kingdom	Royal Manchester Children's Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Schär AG / SPA

Country where clinical trial is conducted

United Kingdom, 

Outcome

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