Clinical trial NCT06623032: Metabolic Effects of Medium-Chain Fatty Acids in Patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals
Official title: Metabolic Effects of Medium-Chain Fatty Acids in Patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medium-chain Acyl-CoA Dehydrogenase Deficiency
Keywords: MCADD
Lipid metabolism
Ketone bodies
Medium-Chain Fatty Acid (MCFA)
Long-Chain Fatty Acid (LCFA)
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Copenhagen Neuromuscular Center
name: Center of Inherited Metabolic Diseases, Copenhagen University Hospital Rigshospitalet
name: Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark
First posted: 2024-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ketone Bodies
timeFrame: During both individual test days
Secondary outcomes:
measure: Resting metabolic rate
timeFrame: During both individual test days
measure: Respiratory exchange ratio
timeFrame: During both individual test days
measure: Vasodilator Function
timeFrame: During both individual test days
measure: Fatty Acid Composition
timeFrame: During both individual test days
measure: Metabolites
timeFrame: During both individual test days
measure: Hepatokines
timeFrame: During both individual test days
measure: Beta cell function
timeFrame: During both individual test days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Andreas M Fritzen, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: