NCT06623032

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Oct 2024Sep 2027

First Submitted

Initial submission to the registry

September 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

October 18, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

September 23, 2024

Last Update Submit

March 9, 2026

Conditions

Medium-chain Acyl-CoA Dehydrogenase Deficiency

Keywords

MCADDLipid metabolismKetone bodiesMedium-Chain Fatty Acid (MCFA)Long-Chain Fatty Acid (LCFA)

Outcome Measures

Primary Outcomes (1)

  • Ketone Bodies

    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 Outcomes (7)

  • Resting metabolic rate

    During both individual test days

  • Respiratory exchange ratio

    During both individual test days

  • Vasodilator Function

    During both individual test days

  • Fatty Acid Composition

    During both individual test days

  • Metabolites

    During both individual test days

  • +2 more secondary outcomes

Study Arms (2)

Healthy Participants

EXPERIMENTAL
Other: Medium-Chain Fatty Acid (MCFA)Other: Long-Chain Fatty Acid (LCFA)

MCADD Patients

EXPERIMENTAL
Other: Medium-Chain Fatty Acid (MCFA)Other: Long-Chain Fatty Acid (LCFA)

Interventions

Medium-Chain Fatty Acid (MCFA)OTHER

The participants will consume Medium-Chain Fatty Acid (MCFA) followed by Long-Chain Fatty Acid (LCFA)

Healthy ParticipantsMCADD Patients
Long-Chain Fatty Acid (LCFA)OTHER

The participants will consume Long-Chain Fatty Acid (LCFA) followed by Medium-Chain Fatty Acid (MCFA).

Healthy ParticipantsMCADD Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Medium chain acyl CoA dehydrogenase deficiency

Study Officials

  • Andreas M Fritzen, Associate Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasper S Jørgensen, PhD student

CONTACT

+4523473023kaspersuhr@sund.ku.dk

Andreas M Fritzen, Associate Professor

CONTACT

amfritzen@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 23, 2024

First Posted

October 2, 2024

Study Start

October 18, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)