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

Not Applicable

Recruiting

• Conditions: Medium-chain Acyl-CoA Dehydrogenase Deficiency

• Registration Number: NCT06623032
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-29
• Status Verified: 2024-10
• Study First Posted: 2024-10-02
• Study Start: 2024-10-18
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Ketone Bodies	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 Outcome Measures

Name	Time	Method
Resting metabolic rate	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.
Vasodilator Function	During both individual test days	To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on vasodilator function.
Fatty Acid Composition	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.
Metabolites	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.
Respiratory exchange ratio	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.
Hepatokines	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.
Beta cell function	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.

Trial Locations

Locations (1)

University of Copenhagen; 🇩🇰 Copenhagen, Denmark