Nutrition, HealthyMediHeartNCT06399354
The Effect of Medium-chain Fatty Acids on Cardiac Function
A study testing acute intake of medium-chain fatty acids or long-chain fatty acids in patients and Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individuals in people with Nutrition, Healthy and Heart Failure, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Heart Failure
- What is being tested?
- acute intake of medium-chain fatty acids or long-chain fatty acids in patients and Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individuals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Aug 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Nutrition, Healthy, Heart Failure
- Being tested
- acute intake of medium-chain fatty acids or long-chain fatty acids in patients, Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individuals
- Keywords
- MCT, Glucose homeostase, ketogenese
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute intake of medium-chain fatty acids or long-chain fatty acids in patientsDietary supplement
The intake of an oil comprising of either medium -chain fatty acids or long-chail fatty acids
Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individualsDietary supplement
Acute intake of MCT and LCT in healthy individuals in a cross-over design
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-5 weeks
Secondary outcomes (3)
Measure of Ketones
Measure the effects of acute medium-chain fatty acid intake on plasma ketone concentration ( in mmol/l) as compared with long-chain fatty acid intake in individuals with and without heart failure.
Measured: 0-5 weeks
Plasma Glucose
measure of plasma glucose concentration (in mmol/l) after the intake of medium-chain fatty acids as compared with the intake of long-chain fatty acids in individuals with and without heart failure
Measured: 0-5 weeks
Measure of plasma lipids
measure of plasma triacylglycerol content in mmol/l after the intake of medium-chain fatty acids as compared with the intake of long-chain fatty acids in individuals with and without heart failure.
Measured: 0-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start20 Aug 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bente Kiens, University of Copenhagen
- Investigators
- Bente Kiens, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399354
- Sponsor's protocol ID
- MediHeart
- Acronym
- MediHeart
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2024
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medium-chain Fatty Acids on Cardiac Function
- ClinicalTrials.gov ID
- NCT06399354
- Acronym / sponsor ID
- MediHeart / MediHeart
- Conditions
- Nutrition, Healthy, Heart Failure
- Keywords
- MCT, Glucose homeostase, ketogenese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Meal test in patients | Experimental | Dietary Supplement: acute intake of medium-chain fatty acids or long-chain fatty acids in patientsEffect of medium-chain fatty acids on heart function measured by cardiac magnetic resonance imaging (CMR) in individuals with heart failure. |
| Meal test in healthy individuals | Experimental | Dietary Supplement: Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individualsAcute intake of a meal comprising either MCT of LCT in healthy individuals and the effects onheart function. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- No use of medications with influence on heart function
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acute 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 supplement | Meal test in patients |
| Acute 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 | Dietary supplement | Meal test in healthy individuals |
Primary outcome
Heart function
Time frame: 0-5 weeks
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.
3 secondary outcomes
Measure of Ketones
Time frame: 0-5 weeks
Plasma Glucose
Time frame: 0-5 weeks
Measure of plasma lipids
Time frame: 0-5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bente Kiens principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acute intake of medium-chain fatty acids or long-chain fatty acids in patients and Acute intake of medium-chain fatty acids or long-chain fatty acids in healthy individuals in people with Nutrition, Healthy and Heart Failure, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart function (time frame: 0-5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.