Market Research - Acceptability Study for New MCT Fat Products

NCT ID: NCT04309214

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2019-01-21

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MCT fats

Intervention Type: DIETARY_SUPPLEMENT

Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period

Interventions

MCT fats

Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

medium chain triglycerides

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Schär AG / SPA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Aberdeen Children's Hospital

Aberdeen, Grampian, United Kingdom

Countries

United Kingdom

Other Identifiers

Kanso 2

Identifier Type: -

Identifier Source: org_study_id