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Completed

NCT Number: NCT04309214

Market Research - Acceptability Study for New MCT Fat Products

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.

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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 Medium Chain Triglycerides Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

3 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Aberdeen Children's Hospital

Aberdeen, Grampian, AB25 2ZG, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

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.

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

Other names: medium chain triglycerides

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) Kanso DeliMCT 53% (Cream) Kanso DeliMCT 28% (Tomato or Mushroom) Kanso DeliMCT 21% (Cacaobar)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
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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