Market Research - Acceptability Study for New MCT Fat Products

NCT04309214 | Completed

• 1 other identifier: Kanso 2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

MCT fats

EXPERIMENTAL

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

Interventions

MCT fats DIETARY_SUPPLEMENT

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

Also known as: medium chain triglycerides

MCT fats

Eligibility Criteria

• Age: 3 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Schär AG / SPA: lead

Study Sites (1)

Royal Aberdeen Children's Hospital

Aberdeen, Grampian, AB25 2ZG, United Kingdom

Location

MeSH Terms

Conditions

Ketosis; Epilepsy; Malabsorption Syndromes

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 16, 2020
• Study Start: November 26, 2018
• Primary Completion: January 21, 2019
• Study Completion: January 21, 2019
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)