Market Research - Acceptability Study for New MCT Fat Products

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)

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Ketosis; Malabsorption; Fatty Acid Oxidation Disorder; Ketogenic Diet; Medium Chain Triglycerides
• Intervention / Treatment: Dietary supplement: MCT fats

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Grampian
    • Aberdeen, Grampian, United Kingdom, AB25 2ZG
      • Royal Aberdeen Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: MCT fats; Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period; Other Names: medium chain triglycerides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Product compliance	Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.	7 days for each product, maximum 25 days
Product palatability	Questionnaire data captured to evaluate taste	7 days for each product, maximum 25 days
Product acceptability	Brief tick-box questionnaire on overall liking and acceptability of product	7 days for each product, maximum 25 days

Collaborators and Investigators

• Sponsor: Dr. Schär AG / SPA

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): January 21, 2019
• Study Completion (Actual): January 21, 2019

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Acid-Base Imbalance; Acidosis; Epilepsy; Malabsorption Syndromes; Ketosis
• Other Study ID Numbers: Kanso 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study will be used for the registration and reimbursement for the products used as foods for special medical purposes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No