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Recruiting NCT06623032

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

No phase Interventional Medium-chain Acyl-CoA Dehydrogenase Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medium-Chain Fatty Acid (MCFA), Long-Chain Fatty Acid (LCFA).
Who it may be relevant to
Registry conditions: Medium-chain Acyl-CoA Dehydrogenase Deficiency. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Ketone Bodies [Time frame: During both individual test days]
Secondary outcome measures (7)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • University of Copenhagen — Copenhagen

Identifiers

NCT: NCT06623032 · H-24044278 · NNF22OC0074110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗