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NCT Number: NCT06623032

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, Denmark

Location status: Recruiting

Location contact

Andreas M Fritzen, Associate Professor

CONTACT

[email protected]

+45 42 63 33 59

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas M Fritzen, Associate Professor

CONTACT

[email protected]

Kasper S Jørgensen, PhD student

CONTACT

[email protected]

+4523473023

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

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

Registry information

Acronym: MEMCADD

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 2, 2024
Registry last updated
Mar 10, 2026

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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