Metabolic Effects of Medium-Chain Fatty Acids in Patients With Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals (MEMCADD)

March 9, 2026 updated by: Andreas Mæchel Fritzen, University of Copenhagen
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • University of Copenhagen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria MCADD patients:

  • Male or female
  • Age between 18-80 years old
  • Diagnosed Medium-chain acyl-CoA dehydrogenase deficiency (MCADD

Inclusion Criteria Healthy Participants:

  • Male or female
  • Age between 18-80 years old

Exclusion Criteria both MCADD patients and healthy participants:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Participants
Other: Medium-Chain Fatty Acid (MCFA)
The participants will consume Medium-Chain Fatty Acid (MCFA) followed by Long-Chain Fatty Acid (LCFA)
Other: Long-Chain Fatty Acid (LCFA)
The participants will consume Long-Chain Fatty Acid (LCFA) followed by Medium-Chain Fatty Acid (MCFA).
Experimental: MCADD Patients
Other: Medium-Chain Fatty Acid (MCFA)
The participants will consume Medium-Chain Fatty Acid (MCFA) followed by Long-Chain Fatty Acid (LCFA)
Other: Long-Chain Fatty Acid (LCFA)
The participants will consume Long-Chain Fatty Acid (LCFA) followed by Medium-Chain Fatty Acid (MCFA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During both individual test days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting metabolic rate
Time Frame: During both individual test days
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on resting metabolic rate.
During both individual test days
Respiratory exchange ratio
Time Frame: During both individual test days
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on respiratory exchange ratio.
During both individual test days
Vasodilator Function
Time Frame: During both individual test days
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on vasodilator function.
During both individual test days
Fatty Acid Composition
Time Frame: During both individual test days
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on fatty acid composition.
During both individual test days
Metabolites
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.
During both individual test days
Hepatokines
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 hepatokine concentrations.
During both individual test days
Beta cell function
Time Frame: During both individual test days
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on Beta cell function.
During both individual test days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark
Copenhagen Neuromuscular Center
Center of Inherited Metabolic Diseases, Copenhagen University Hospital Rigshospitalet

Investigators

  • Principal Investigator: Andreas M Fritzen, Associate Professor, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 29, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24044278
  • NNF22OC0074110 (Other Grant/Funding Number: Novo Nordisk Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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