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OpenTrials
Completed

NCT Number: NCT04309149

Market Research - Acceptability Study for a Range of MCT Products

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

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Key information

Conditions

Ketosis Acid-Base Imbalance Acidosis Brain Diseases Central Nervous System Diseases Digestive System Diseases Epilepsy Fatty Acid Oxidation Disorder Gastrointestinal Diseases Intestinal Diseases Ketogenic Diet Malabsorption Malabsorption Syndromes Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

2 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bristol Royal Hospital for Children, Bristol, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Gastrointestinal tolerance

    Time frame: 7 days for each product, maximum 25 days

    Questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product

  2. Product compliance

    Time frame: 7 days for each product, maximum 25 days

    Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.

  3. Product palatability

    Time frame: 7 days for each product, maximum 25 days

    Questionnaire data captured to evaluate taste

  4. Product acceptability

    Time frame: 7 days for each product, maximum 25 days

    Brief tick-box questionnaire on overall liking and acceptability of product

Sponsors and collaborators

Lead sponsor

Dr. Schär AG / SPA

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2020
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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