An interventional study of MCT fats in Ketosis, Epilepsy and Fatty Acid Oxidation Disorder, sponsored by Dr. Schär AG / SPA. Completed at 1 site in United Kingdom. Open to participants aged 3 Years to 20 Years. Per ClinicalTrials.gov, last updated 2020-03-16.
Sponsored by Dr. Schär AG / SPA · Not applicable, Interventional, and Other
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.
218 studies on the registry are indexed under Ketosis; 50 are open to participants now.
This study's enrollment of 12 is below the median of 20 across 190 interventional studies indexed under Ketosis.
Browse Ketosis studies →Dr. Schär AG / SPA is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Gastrointestinal tolerance
Questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product
Time frame: 7 days for each product, maximum 25 days
Product compliance
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Time frame: 7 days for each product, maximum 25 days
Product palatability
Questionnaire data captured to evaluate taste
Time frame: 7 days for each product, maximum 25 days
Product acceptability
Brief tick-box questionnaire on overall liking and acceptability of product
Time frame: 7 days for each product, maximum 25 days
Plan to share: No — This study will be used for the registration and reimbursement for the products used as foods for special medical purposes.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SMOFlipid
Dr. Schär AG / SPA