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CompletedNCT04309149Updated Mar 16, 2020

Market Research - Acceptability Study for a Range of MCT Products

An interventional study of MCT fats in Ketosis, Epilepsy and Ketogenic Diet, sponsored by Dr. Schär AG / SPA. Completed at 2 sites in United Kingdom. Open to participants aged 2 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-03-16.

Sponsored by Dr. Schär AG / SPA · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2018, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
2 Years to 60 Years
Sex
All
01

Study 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

02

Conditions studied

  • Ketosis
  • Epilepsy
  • Ketogenic Diet
  • Fatty Acid Oxidation Disorder
  • Malabsorption
03

In context

Ketosis

195 studies on the registry are indexed under Ketosis; 41 are open to participants now.

This study's enrollment of 12 is below the median of 24 across 156 interventional studies indexed under Ketosis.

Browse Ketosis studies →

Lead sponsor

Dr. Schär AG / SPA is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    MCT fats

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

    Dietary Supplement: MCT fats

Interventions

  • Dietary supplementMCT fats

    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).

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Product palatability

    Questionnaire data captured to evaluate taste

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

  4. Product acceptability

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

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

07

Study locations

2 sites
  • Bristol Royal Hospital for Children
    Bristol, BS2 8BJ, United Kingdom
  • Royal Manchester Children's Hospital
    Manchester, M13 9WL, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — This study will be used to demonstrate acceptability for registration and reimbursement of these foods for special medical purposes.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Jan 2020, 14 months.

Of 79 interventional studies with no phase under Ketosis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 24. This study's 14 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2020
First posted
Mar 16, 2020
StartActual
Nov 1, 2018
Primary completionActual
Jan 31, 2020
CompletionActual
Jan 31, 2020
Last update
Mar 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04309149
Lead sponsor
Dr. Schär AG / SPA
Responsible party
Sponsor
First posted
Mar 16, 2020
Start date
Nov 1, 2018
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020
Last update
Mar 16, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Other studies in this condition

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Dr. Schär AG / SPA

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