Medium-chain Acyl-CoA Dehydrogenase DeficiencyMEMCADDNCT06623032
Metabolic Effects of Medium-Chain Fatty Acids in Patients With Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals
A study testing Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) in people with Medium-chain Acyl-CoA Dehydrogenase Deficiency, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this project is to investigate the physiological effects of intake of long-chain fatty acids (LCFA) and medium-chain fatty acids (MCFA) in patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) and healthy individuals Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Medium-chain Acyl-CoA Dehydrogenase Deficiency
- What is being tested?
- Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Oct 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Age between 18-80 years old
- Diagnosed Medium-chain acyl-CoA dehydrogenase deficiency (MCADD
- Male or female
- Age between 18-80 years old
- Exclusion Criteria both MCADD patients and healthy participants:
Show all 14Show fewer
- Diabetes
- Kidney- or liver disease
- Use of beta blockers or diuretics
- Pregnant, lactating or planning to become pregnant within the study period
- Regular intake of substantial amounts of coconut oil, palm kernel oil or any other source abundant in MCFA
- Ongoing cancer treatment
- Metabolic or absorptive disorders, gastric bypass operation, or use of medication affecting metabolism or food absorption
- Inability, physically or mentally, to comply with the procedure required by the study protocol as evaluated by the primary investigator, study manager or clinical responsible
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andreas M Fritzen, Associate Professor contact
Denmark1 site, 1 recruiting
- Recruiting
University of Copenhagen
Copenhagen
Andreas M Fritzen, Associate Professor, +45 42 63 33 59, amfritzen@sund.ku.dk
About this study
The aim of this project is to investigate the physiological effects of intake of long-chain fatty acids (LCFA) and medium-chain fatty acids (MCFA) in patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) and healthy individuals
Read the detailed description
Male and female MCADD patients and healthy individuals will be included in this study which is a randomized intervention study in a cross over design consisting of two separate test days.
The study involves two test days of four hours each, during which the participants ingests either medium-chain fatty acids (MCFA) or long-chain fatty acids (LCFA) in the form of triacylglycerol oils. The order of fatty acid oils ingested is determined by randomization.
Furthermore, a 3rd test day will be performed to evaluate ectopic fat deposition in the liver and the heart by using MRI scans, with no prior intake of MCFA or LCFA.
- Being tested
- Medium-Chain Fatty Acid (MCFA), Long-Chain Fatty Acid (LCFA)
- Keywords
- MCADD, Lipid metabolism, Ketone bodies, Medium-Chain Fatty Acid (MCFA), Long-Chain Fatty Acid (LCFA)
- Medical subject headings
- Medium chain acyl CoA dehydrogenase deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium-Chain Fatty Acid (MCFA)Other
The participants will consume Medium-Chain Fatty Acid (MCFA) followed by Long-Chain Fatty Acid (LCFA)
Long-Chain Fatty Acid (LCFA)Other
The participants will consume Long-Chain Fatty Acid (LCFA) followed by Medium-Chain Fatty Acid (MCFA).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | Not described Receives: Other: Medium-Chain Fatty Acid (MCFA); Other: Long-Chain Fatty Acid (LCFA) |
| MCADD Patients | Experimental | Not described Receives: Other: Medium-Chain Fatty Acid (MCFA); Other: Long-Chain Fatty Acid (LCFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ketone Bodies
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on circulating ketone body concentrations.
Measured: During both individual test days
Secondary outcomes (8)
Resting metabolic rate
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on resting metabolic rate.
Measured: During both individual test days
Respiratory exchange ratio
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on respiratory exchange ratio.
Measured: During both individual test days
Vasodilator Function
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on vasodilator function.
Measured: During both individual test days
Fatty Acid Composition
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on fatty acid composition.
Measured: During both individual test days
Metabolites
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on circulating ketone body concentrations.
Measured: During both individual test days
Hepatokines
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on circulating hepatokine concentrations.
Measured: During both individual test days
Beta cell function
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on Beta cell function.
Measured: During both individual test days
Ectopic Fat Deposition
MRI scans will be performed to evaluate ectopic fat deposition in the liver and the heart with no prior intake of MCFA or LCFA.
Measured: On a separate 3rd test day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start18 Oct 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medium-chain Acyl-CoA Dehydrogenase DeficiencyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Neuromuscular Center, Center of Inherited Metabolic Diseases, Copenhagen University Hospital Rigshospitalet, Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark
- Responsible party
- Principal investigator, Andreas Mæchel Fritzen, University of Copenhagen
- Investigators
- Andreas M Fritzen, Associate Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623032
- Sponsor's protocol ID
- H-24044278
- Other IDs
- NNF22OC0074110
- Acronym
- MEMCADD
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Medium-Chain Fatty Acids in Patients With Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals
- ClinicalTrials.gov ID
- NCT06623032
- Acronym / sponsor ID
- MEMCADD / H-24044278
- Keywords
- MCADD, Lipid metabolism, Ketone bodies, Medium-Chain Fatty Acid (MCFA), Long-Chain Fatty Acid (LCFA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen Neuromuscular Center, Center of Inherited Metabolic Diseases, Copenhagen University Hospital Rigshospitalet, Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to investigate the physiological effects of intake of long-chain fatty acids (LCFA) and medium-chain fatty acids (MCFA) in patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) and healthy individuals
Detailed description
Male and female MCADD patients and healthy individuals will be included in this study which is a randomized intervention study in a cross over design consisting of two separate test days.
The study involves two test days of four hours each, during which the participants ingests either medium-chain fatty acids (MCFA) or long-chain fatty acids (LCFA) in the form of triacylglycerol oils. The order of fatty acid oils ingested is determined by randomization.
Furthermore, a 3rd test day will be performed to evaluate ectopic fat deposition in the liver and the heart by using MRI scans, with no prior intake of MCFA or LCFA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Other: Medium-Chain Fatty Acid (MCFA), Other: Long-Chain Fatty Acid (LCFA) |
| MCADD Patients | Experimental | Other: Medium-Chain Fatty Acid (MCFA), Other: Long-Chain Fatty Acid (LCFA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female
- Age between 18-80 years old
- Diagnosed Medium-chain acyl-CoA dehydrogenase deficiency (MCADD
- Male or female
- Age between 18-80 years old
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium-Chain Fatty Acid (MCFA)The participants will consume Medium-Chain Fatty Acid (MCFA) followed by Long-Chain Fatty Acid (LCFA) | Other | Healthy Participants, MCADD Patients |
| Long-Chain Fatty Acid (LCFA)The participants will consume Long-Chain Fatty Acid (LCFA) followed by Medium-Chain Fatty Acid (MCFA). | Other | Healthy Participants, MCADD Patients |
Primary outcome
Ketone Bodies
Time frame: During both individual test days
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on circulating ketone body concentrations.
8 secondary outcomes
Resting metabolic rate
Time frame: During both individual test days
Respiratory exchange ratio
Time frame: During both individual test days
Vasodilator Function
Time frame: During both individual test days
Fatty Acid Composition
Time frame: During both individual test days
Metabolites
Time frame: During both individual test days
Hepatokines
Time frame: During both individual test days
Beta cell function
Time frame: During both individual test days
Ectopic Fat Deposition
Time frame: On a separate 3rd test day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Medium-chain Acyl-CoA Dehydrogenase Deficiency
RecruitingPhase 2
Study of Sodium Phenylbutyrate (ACER-001) for the Treatment of Pediatric and Adults Patients With Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCADD)
Medium-chain Acyl-CoA Dehydrogenase Deficiency
Active, not recruitingPhase 3
A Study to Determine the Effect of Triheptanoin Compared With Even-Chain MCT on MCEs in Pediatric Patients With LC-FAOD
Long-chain Fatty Acid Oxidation Disorders (LC-FAOD)
RecruitingObservational study
Natural History of MADD
Multiple Acyl-CoA Dehydrogenase Deficiency
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Active, not recruitingObservational study
Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program
Long-chain Fatty Acid Oxidation Disorders (LC-FAOD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas M Fritzen, Associate Professor contact
Andreas M Fritzen, Associate Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) in people with Medium-chain Acyl-CoA Dehydrogenase Deficiency, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kasper S Jørgensen, PhD student (+4523473023, kaspersuhr@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ketone Bodies (time frame: During both individual test days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.