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Market Research - Acceptability Study for New MCT Fat Products

Primary Purpose

Ketosis, Epilepsy, Fatty Acid Oxidation Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MCT fats
Sponsored by
Dr. Schär AG / SPA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ketosis

Eligibility Criteria

3 Years - 20 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Royal Aberdeen Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MCT fats

Arm 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.

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

First Posted
March 9, 2020
Last Updated
March 12, 2020
Sponsor
Dr. Schär AG / SPA
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1. Study Identification

Unique Protocol Identification Number
NCT04309214
Brief Title
Market Research - Acceptability Study for New MCT Fat Products
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
January 21, 2019 (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, young people and adults with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis, Epilepsy, Fatty Acid Oxidation Disorder, Malabsorption, Ketogenic Diet, Medium Chain Triglycerides

7. Study Design

Primary Purpose
Other
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
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
MCT fats
Other Intervention Name(s)
medium chain triglycerides
Intervention Description
Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period
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
3 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Grampian
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study will be used for the registration and reimbursement for the products used as foods for special medical purposes.

Learn more about this trial

Market Research - Acceptability Study for New MCT Fat Products

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