Market Research - Acceptability Study for New MCT Fat Products

Epilepsy Clinical Trial

Official title:

Market Research - Acceptability Study for a Range of New MCT Based Products (Dr Schär - Kanso) Kanso DeliMCT 53% (Cream) Kanso DeliMCT 28% (Tomato or Mushroom) Kanso DeliMCT 21% (Cacaobar)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309214
• Other study ID #: Kanso 2
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: January 21, 2019

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, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Fatty Acid Oxidation Disorder
• Ketogenic Diet
• Ketosis
• Malabsorption
• Malabsorption Syndromes
• Medium Chain Triglycerides

Intervention

Dietary Supplement:
• MCT fats
Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period

Locations

Country	Name	City	State
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen	Grampian

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