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CompletedNCT06399354

The Effect of Medium-chain Fatty Acids on Cardiac Function

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
University of Copenhagen · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

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.

Detailed description

The study will be conducted as a block-randomized cross-over study in participants with heart failure (HFrEF) (n=10) and in healthy age- and BMI-matched participants with normal heart function (n=13) as control group. The participants will undergo two experimental days separated by a two to four weeks wash-out period. At the test days, participants will consume cocoa milk added 0.5g/kg body weight of medium-chain fatty acid oil or long-chain fatty acid oil as control. Two days prior to metabolic testing, participants will consume a controlled diet. The controlled diet will be handed out to the participant. Initially, potential participants are invited to an information meeting and after informed consent a screening is performed. Following inclusion, one of two identical test days are conducted consuming either medium-chain fatty acids or long-chain fatty acids in a randomized order. The participants will arrive after a 4 h period with no intake of food and drinks except water, and by passive transport (train, bus or car). After 30 min of rest in the supine position, venflon catheters are inserted into the right and left antecubital vein. After insertion of the catheters, fasting venous blood samples are drawn (20 ml in total) from one of the catheters for analysis of ketones, glucose, insulin, C-peptide, fatty acids, triacylglycerol, lipidomics and concentration of hepatokines. ECG monitoring is initiated. Thereafter, the first basal CMR will be performed. After the basal blood sampling and scanning, the participants consume the cocoa-drink with 60g medium-chain fatty acid or 60g long-chain fatty acid and remains resting for the following 4 hours. Venous blood samples (15 ml) are obtained at 0, 30, 60, 80 and 135 min In total, up to 110 ml blood is obtained during the test day. At 90 min, the CMR will be repeated. At the end of the test day, the participant is served a meal. The duration of the test day is 4 hours. After a wash-out period of 2-4 weeks the test day will be repeated with consumption of the other fatty acid type.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTacute intake of medium-chain fatty acids or long-chain fatty acids in patientsThe intake of an oil comprising of either medium -chain fatty acids or long-chail fatty acids
DIETARY_SUPPLEMENTAcute intake of medium-chain fatty acids or long-chain fatty acids in healthy individualsAcute intake of MCT and LCT in healthy individuals in a cross-over design

Timeline

Start date
2024-08-20
Primary completion
2025-04-01
Completion
2025-04-01
First posted
2024-05-03
Last updated
2025-04-06

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06399354. Inclusion in this directory is not an endorsement.