Heart Failure With Reduced Ejection FractionKETONE-HFNCT05348460
Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure
A study testing Ketone ester drink (DeltaG®, 500 mg/kg body weight) in people with Heart Failure With Reduced Ejection Fraction and Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Heart Failure
- What is being tested?
- Ketone ester drink (DeltaG®, 500 mg/kg body weight)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Feb 2022to 1 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Heart Failure NYHA II - III
- LVEF ≤40%
- Stable for the last 1 month prior to the study
Who cannot join
- Age <18 years;
- Unable or unwilling to undergo exercise MRI (physical disabilities, claustrophobia);
- Unable to complete the exercise protocol during the screening visit according to the professional opinion of the investigators;
- Comorbidities which can influence study results such as muscular dystrophies, peripheral artery disease, diabetes mellitus, severe anaemia (defined as Hb ≤6 mmol/L);
- Pregnant/trying to get pregnant/breastfeeding during the period from the first exercise test until 4 weeks after the last exercise test);
- Absolute contra-indications to undergo MRI according to the current UMCG protocols and guidelines (e.g. non-conditional medical device, recent device implantation, incompatible ferromagnetic objects in the body).
Show all 9Show fewer
- BMI < 16 kg/m2; BMI > 35 kg/m2
- Unable to understand study procedures;
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
Read the detailed description
The goal of this study is to investigate if oral ketone supplementation stimulates mitochondrial ATP production and improves exercise performance in patients with chronic HF. In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment. Endpoints include rate and magnitude of change in phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise, rate and magnitude of change in PCr and Pi concentrations during recovery, rates and magnitude of change in intramuscular pH during exercise and recovery, maximal exercise performance and change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise.
- Being tested
- Ketone ester drink (DeltaG®, 500 mg/kg body weight), Taste-matched, isovolumic placebo drink
- Keywords
- Heart Failure, Ketone Body, HFrEF, Skeletal Muscle Metabolism, Mitochondrial Ketone Oxidation, 31P MRS, Pi/Pcr
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone ester drink (DeltaG®, 500 mg/kg body weight)Dietary supplement
In a double blind fashion, subjects will receive a ketone ester drink ór a taste-matched, isovolumic placebo drink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
Taste-matched, isovolumic placebo drinkDietary supplement
In a double blind fashion, subjects will receive a ketone ester drink ór a taste-matched, isovolumic placebo drink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
| Study group | Role | What they receive |
|---|---|---|
| Ketone - Placebo treatment | Other | Patients will first receive a supplemental drink containing a ketone ester before performing the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time after receiving the placebo treatment. Receives: Dietary Supplement: Ketone ester drink (DeltaG®, 500 mg/kg body weight); Dietary Supplement: Taste-matched, isovolumic placebo drink |
| Placebo - Ketone treatment | Other | Patients will first receive a placebodrink before performing the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time after receiving the supplemental drink containing a ketone ester. Receives: Dietary Supplement: Ketone ester drink (DeltaG®, 500 mg/kg body weight); Dietary Supplement: Taste-matched, isovolumic placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise
Rate and magnitude of change in PCr and Pi concentrations from baseline to maximum exercise.
Measured: During study-visit
Secondary outcomes (4)
Rate and magnitude of change in PCr and Pi concentrations during recovery
Rate and magnitude of change in PCr and Pi concentrations during recovery of change in PCr and Pi is expressed as change in Pi/PCr (ΔPi/PCr)
Measured: During study visit
Intramuscular pH
Rates and magnitude of change in intramuscular pH during exercise and recovery
Measured: During study visit
Maximal exercise performance
Maximal exercise performance
Measured: During study visit
Change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise
Change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise
Measured: During study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start15 Feb 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled cross-over design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Daan Westenbrink, MD PhD, Principal investigator, Unversity Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348460
- Sponsor's protocol ID
- 201900710
- Acronym
- KETONE-HF
- Status last verified
- May 2024
- First submitted
- 4 Mar 2022
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05348460
- Acronym / sponsor ID
- KETONE-HF / 201900710
- Keywords
- Heart Failure, Ketone Body, HFrEF, Skeletal Muscle Metabolism, Mitochondrial Ketone Oxidation, 31P MRS, Pi/Pcr
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 27 Apr 2022 (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.
In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
Detailed description
The goal of this study is to investigate if oral ketone supplementation stimulates mitochondrial ATP production and improves exercise performance in patients with chronic HF. In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment. Endpoints include rate and magnitude of change in phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise, rate and magnitude of change in PCr and Pi concentrations during recovery, rates and magnitude of change in intramuscular pH during exercise and recovery, maximal exercise performance and change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled cross-over design
| Arm | Type | Receives |
|---|---|---|
| Ketone - Placebo treatment | Other | Dietary Supplement: Ketone ester drink (DeltaG®, 500 mg/kg body weight), Dietary Supplement: Taste-matched, isovolumic placebo drinkPatients will first receive a supplemental drink containing a ketone ester before performing the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time after receiving the placebo treatment. |
| Placebo - Ketone treatment | Other | Dietary Supplement: Ketone ester drink (DeltaG®, 500 mg/kg body weight), Dietary Supplement: Taste-matched, isovolumic placebo drinkPatients will first receive a placebodrink before performing the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time after receiving the supplemental drink containing a ketone ester. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic Heart Failure NYHA II - III
- LVEF ≤40%
- Stable for the last 1 month prior to the study
Key exclusion criteria (9 listed)
- Age <18 years;
- Unable or unwilling to undergo exercise MRI (physical disabilities, claustrophobia);
- Unable to complete the exercise protocol during the screening visit according to the professional opinion of the investigators;
- Comorbidities which can influence study results such as muscular dystrophies, peripheral artery disease, diabetes mellitus, severe anaemia (defined as Hb ≤6 mmol/L);
- Pregnant/trying to get pregnant/breastfeeding during the period from the first exercise test until 4 weeks after the last exercise test);
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 |
|---|---|---|
| Ketone ester drink (DeltaG®, 500 mg/kg body weight)In a double blind fashion, subjects will receive a ketone ester drink ór a taste-matched, isovolumic placebo drink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment. | Dietary supplement | Ketone - Placebo treatment, Placebo - Ketone treatment |
| Taste-matched, isovolumic placebo drinkIn a double blind fashion, subjects will receive a ketone ester drink ór a taste-matched, isovolumic placebo drink and will then perform the 31P MRS exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment. | Dietary supplement | Ketone - Placebo treatment, Placebo - Ketone treatment |
Primary outcome
Phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise
Time frame: During study-visit
Rate and magnitude of change in PCr and Pi concentrations from baseline to maximum exercise.
4 secondary outcomes
Rate and magnitude of change in PCr and Pi concentrations during recovery
Time frame: During study visit
Intramuscular pH
Time frame: During study visit
Maximal exercise performance
Time frame: During study visit
Change in concentrations of beta-hydroxybutyrate and other metabolites before consumption of the supplemental drink, after consumption of the supplemental drink and after exercise
Time frame: During study visit
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 3 May 2024.
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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.
Daan Westenbrink, MD PhD principal investigator
Unversity Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone ester drink (DeltaG®, 500 mg/kg body weight) in people with Heart Failure With Reduced Ejection Fraction and Heart Failure, run by University Medical Center Groningen at 1 site in Netherlands.
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 3 inclusion and 9 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 3 May 2024. 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 Netherlands. 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?
Phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise (time frame: During study-visit). 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 3 May 2024.