Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06399354 |
Other study ID # |
MediHeart |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 20, 2024 |
Est. completion date |
December 15, 2025 |
Study information
Verified date |
May 2024 |
Source |
University of Copenhagen |
Contact |
Bente Kiens |
Phone |
+4528751619 |
Email |
bkiens[@]nexs.ku.dk |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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=20) 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, this time also including administration of the gadolinium contrast agent gadobutrol
(Gadovist, Bayer, DE) (used for imaging of the heart and for myocardial perfusion imaging).
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.