Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399354
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-09
Brief Title:
The Effect of Medium-chain Fatty Acids on Cardiac Function
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
The Effect of Medium-chain Fatty Acids on Cardiac Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MediHeart
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
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 n10 and in healthy age- and BMI-matched participants with normal heart function n20 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 05gkg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None