Market Research - Acceptability Study for a Range of MCT Products

NCT04309149 | Completed

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

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

Conditions

Ketosis; Epilepsy; Ketogenic Diet; Fatty Acid Oxidation Disorder; Malabsorption

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

Kanso MCT oils and margarine will be consumed daily for 7 days each to assess tolerability and compliance

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 (21 days taking the new products with 2 days between each new product trialled).

MCT fats

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

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 less than 3 years of age.

Sponsors & Collaborators

• Dr. Schär AG / SPA: lead

Study Sites (2)

Bristol Royal Hospital for Children

Bristol, BS2 8BJ, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, M13 9WL, 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: BASIC SCIENCE
• 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 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)