Back to resultsMarket Research - Acceptability Study for a Range of MCT Products
Primary Purpose
Ketosis, Epilepsy, Ketogenic Diet
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MCT fats
Sponsored by
About this trial
This is an interventional basic science trial for Ketosis
Eligibility Criteria
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.
Sites / Locations
- Bristol Royal Hospital for Children
- Royal Manchester Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MCT fats
Arm Description
Kanso MCT oils and margarine will be consumed daily for 7 days each to assess tolerability and compliance
Outcomes
Primary Outcome Measures
Gastrointestinal tolerance
Questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product
Product compliance
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Product palatability
Questionnaire data captured to evaluate taste
Product acceptability
Brief tick-box questionnaire on overall liking and acceptability of product
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04309149
Brief Title
Market Research - Acceptability Study for a Range of MCT Products
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Schär AG / SPA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis, Epilepsy, Ketogenic Diet, Fatty Acid Oxidation Disorder, Malabsorption
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCT fats
Arm Type
Experimental
Arm Description
Kanso MCT oils and margarine will be consumed daily for 7 days each to assess tolerability and compliance
Intervention Type
Dietary Supplement
Intervention Name(s)
MCT fats
Intervention Description
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).
Primary Outcome Measure Information:
Title
Gastrointestinal tolerance
Description
Questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product
Time Frame
7 days for each product, maximum 25 days
Title
Product compliance
Description
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Time Frame
7 days for each product, maximum 25 days
Title
Product palatability
Description
Questionnaire data captured to evaluate taste
Time Frame
7 days for each product, maximum 25 days
Title
Product acceptability
Description
Brief tick-box questionnaire on overall liking and acceptability of product
Time Frame
7 days for each product, maximum 25 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Bristol Royal Hospital for Children
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This study will be used to demonstrate acceptability for registration and reimbursement of these foods for special medical purposes.
Learn more about this trial
Market Research - Acceptability Study for a Range of MCT Products
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