The Effect of Medium-chain Fatty Acids on Cardiac Function

NCT06399354 | Completed

• 1 other identifier: MediHeart
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of an acute intake of medium-chain fatty acids on heart function measured by cardiac magnetic resonance imaging (CMR) will be measured in individuals with heart failure with reduced ejection fraction (HFrEF) and in matched healthy controls with normal heart function. This aim will be investigated in a cross-over study including two visits: acute intake of medium-chain fatty acid or long-chain fatty acid as control. In addition, the effect of acute medium-chain fatty acid compared with long-chain fatty acid intake on whole-body lipid and glucose metabolism will be investigated.. The hypothesis is that acute consumption of medium-chain fatty acid will improve cardiac function in patients with heart failure.

Conditions

Nutrition, Healthy; Heart Failure

Keywords

MCT; Glucose homeostase; ketogenese

Outcome Measures

Primary Outcomes (1)

• Heart function

  To investigate the effect of acute medium-chain fatty acids intake on heart function assessed by cardiac output (l/min) measured by cardiac magnetic resonance imaging (CMR) in individuals with heart failure with reduced ejection fraction (HFrEF) and in matched healthy controls with normal heart function.

  0-5 weeks

Secondary Outcomes (3)

• Measure of Ketones

  0-5 weeks

• Plasma Glucose

  0-5 weeks

• Measure of plasma lipids

  0-5 weeks

Study Arms (2)

Meal test in patients

EXPERIMENTAL

Effect of medium-chain fatty acids on heart function measured by cardiac magnetic resonance imaging (CMR) in individuals with heart failure.

Dietary Supplement: acute intake of medium-chain fatty acids or long-chain fatty acids in patients

Meal test in healthy individuals

EXPERIMENTAL

Acute intake of a meal comprising either MCT of LCT in healthy individuals and the effects onheart function.

Dietary Supplement: Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individuals

Interventions

acute intake of medium-chain fatty acids or long-chain fatty acids in patients DIETARY_SUPPLEMENT

The intake of an oil comprising of either medium -chain fatty acids or long-chail fatty acids

Meal test in patients

Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individuals DIETARY_SUPPLEMENT

Acute intake of MCT and LCT in healthy individuals in a cross-over design

Meal test in healthy individuals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart failure with reduced ejection fraction; I. Left ventricular ejection fraction ≤45% and optimal, stable HFrEF treatment according to guidelines II. Functional classification New York Heart Association class II-III.
• No uncorrected cardiac valvular disease
• No signs or symptoms of myocardial infarction within the previous 3 months
• No permanent of persistent arterial fibrillation.
• For controls:
• No use of medications with influence on heart function

You may not qualify if:

• Diabetes, kidney or liver disease.
• Contraindications to CMR, e.g., abdominal height exceed limitations of the MR- scanner, pacemaker, stent, neurostimulator, or other electronic device implanted, implanted metal devices, severe claustrophobia, or physiological diseases
• Pregnant, lactating or planning to become pregnant within the study period
• To ensure safety, no gadobutrol contrast can be administrered to participants with severe reduced kidney function, indicated by glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2, accessed from the obtained screening blood sample or from the Patient Record. In such cases, potential participants will be excluded from the study.
• Blood donation during and \< 3 month prior to study
• Simultaneous participation in other clinical trials
• Inability, physically or mentally, to comply with the procedure required by the study protocol ad evaluated by the primary investigator, study manager or clinical responsible

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bente Kiens

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A parallel, cross-over study in participants with heart failure and in a healthy age- and BMI-matched participants with normal heart function as control group.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 3, 2024
• Study Start: August 20, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DK (1)