Healthy VolunteersEarly Phase 1NCT02814474
Effects of Experimental Hyperketonemia on Myocardial Metabolism
A Early Phase 1 study testing Na-3-hydroxybutyrate and Saline in people with Healthy Volunteers, run by University of Aarhus at 2 sites in Denmark.
Trial summary
Starvation and metabolic stress increase circulating ketone bodies, potentially providing the heart with an alternative oxidative fuel. Hyperketonemia reduces myocardial fatty acid consumption. It is unclear whether this is due to inhibited peripheral lipolysis or diminished uptake per se. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Na-3-hydroxybutyrate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2014to Jun 2016
- Phase
- Early Phase 1
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Decreased cardiac function
- Kidney disease
- Pulmonary disease
- Current malignant disease
- Substance abuse
- Blood donation within 6 month prior to the study
- Participation in studies involving ionising radiation within 12 month prior to the study
- Known claustrophobia
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Nuclear Medicine & PET Center, Aarhus University Hospital
Aarhus, 8000
Medical Research Laboratories
Aarhus, 8000
About this study
Official title: Impact of Ketone Bodies on Myocardial Glucose and Fatty Acid Metabolism in Healthy Volunteers: A Positron Emission Tomography Study
Starvation and metabolic stress increase circulating ketone bodies, potentially providing the heart with an alternative oxidative fuel. Hyperketonemia reduces myocardial fatty acid consumption. It is unclear whether this is due to inhibited peripheral lipolysis or diminished uptake per se.
Aim: To test whether infusion of 3-hydroxybutyrate (BHB) inhibits myocardial glucose and fatty acid uptake.
Methods: Randomized, single blinded, cross-over interventional study in 8 healthy volunteers. Myocardial glucose and fatty acid metabolism studied by 11C-palmitate and 18F-FDG PET/CT. Experimental elevation of circulating ketone bodies by infusion of β-hydroxy-β-methylbutyrate.
Read the detailed description
Background:
Ketone bodies are produced by the liver in conditions of increased fatty acid oxidation, serving as important fuel sources during fasting and starvation. They are metabolized to acetyl-CoA which enters the tricarboxylic acid cycle, enabling ATP production independently of glycolysis and resulting in lower oxygen consumption per mole of produced ATP compared to glucose [ref]. Their primary physiological function appears to be as an alternative protein-sparing source of energy for extrahepatic tissues in times of reduced carbohydrate availability, preventing muscle wasting. The principal ketone bodies in humans are beta-hydroxybutyrate (BHB) and acetoacetate. Increased ketogenesis is a feature common to fasting, starvation and diabetes mellitus. Ketones have been shown to have a number of neuroprotective effects including anticonvulsant activity, improving cognitive function in Alzheimer's disease and decreasing the effects of acute brain injury and ischemic damage [ref], as well as antitumoral effect in gliomas. This has led to the suggestion that ketones could be used therapeutically for a number of diseases though currently the only recognized therapeutic use of ketones is in the form of ketogenic diets for the treatment of epilepsy.
There are limited in vivo studies on the effect of ketones on the heart. It is known that fatty acids are the preferred myocardial fuel substrate and that this shifts to increased use of glucose, and to a lesser extent ketones, in times of acutely increased demand. Interestingly, acute ketone infusion in pigs appears to inhibit myocardial fatty acid oxidation. In vitro studies suggest ketones decrease myocardial glucose uptake and affect myocardial contractility, with either increased or decreased contractility when ketones are the only energy source. This has not been further investigated in vivo. It is therefore unclear to what extent ketones can contribute to myocardial metabolism in conditions of hyperketonemia, and how this affects contractility.
The present project thus proposes to address the issues outlined above, by measuring human cerebral and cardiac uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers, under experimental hyperketonemia.
Hypotheses:
- An acute increase in blood ketone concentration without previous ketoadaptation will decrease cardiac palmitate and glucose uptake in healthy humans.
Materials and methods
Effect of acute ketone infusion on cardiac perfusion and 18F-FDG and 11C-palmitate uptake in healthy subjects:
Study population: 10 healthy volunteers. All study subjects will be instructed to follow a standardised diet for 1 week before the study. On the study day, they will undergo a baseline dynamic cardiac PET scan with 15O-water followed by 11C-palmitate and 18F-FDG tracers, together with baseline blood samples, muscle biopsy and subcutaneous fat biopsy to assess peripheral metabolic status. An intravenous infusion of sodium betahydroxybutyrate will then be initiated at a concentration and rate sufficient to achieve 1-2 mM ketonemia after 30 minutes (assessed by blood sample). A second dynamic PET scan identical to the first will then be performed under continuous ketone infusion at a constant rate. Finally, a second set of blood samples, muscle and subcutaneous fat biopsies will be taken after the scan before stopping the ketone infusion.
Perspectives:
The results of this research are expected to provide insights into how human heart metabolism respond to increased ketone bodies, and whether there are significant functional improvements. It should contribute to further understanding the possible therapeutic benefits of both exogenous ketone administration and of fasting in relation to cardiac function, with implications for the treatment of various diseases such as diabetes and heart failure. Knowledge of ketones' effects on the kinetics of various radionuclide tracers also has importance for the appropriate clinical use of diagnostic PET scans in patients with elevated blood ketone levels. In addition, the implementation and validation of a ketone PET tracer will allow further future non-invasive studies that directly measure ketone metabolism in various tissues and disease states.
- Conditions
- Healthy Volunteers
- Being tested
- Na-3-hydroxybutyrate, Saline
- Keywords
- PET/CT, Heart failure, hydroxybutyrate
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Na-3-hydroxybutyrateOther
Infusion of Na-3-hydroxybutyrate (0.18 g/kg/hour) for 390 minutes
SalineOther
Infusion of 0.9 % saline
| Study group | Role | What they receive |
|---|---|---|
| SALINE | Placebo comparator | Infusion of saline (0.9 %) Receives: Other: Saline |
| KETONE | Experimental | Infusion of Na-3-Hydroxybutyrate (0.18 g/kg/hour) for 390 minutes Receives: Other: Na-3-hydroxybutyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Glucose uptake
Dynamic 18F-FDG PET/CT scan - 50 minutes
Measured: After 330 minutes of ketone infusion
Myocardial Fatty Acid Metabolism
Dynamic 11C-palmitate PET/CT scan - 50 minutes
Measured: After 210 minutes of ketone infusion
Myocardial Blood Flow
Dynamic 15O-H2O PET/CT scan - 6 minutes
Measured: After 180 minutes of ketone infusion
Secondary outcomes (1)
Insulin sensitivity
Glucose infusion rate (GIR) during a 0.3 mIE/kg/min hyperinsulinemic- euglycemic clamp
Measured: Time 0-390 of the ketone body infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Niels Møller, MD DMsc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814474
- Sponsor's protocol ID
- 1-10-72-104-14
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Svart M, Gormsen LC, Espersen R, Rittig N, Starup-Linde J, Moller N, Rejnmark L. 3-Hydroxybutyrate administration elevates plasma parathyroid hormone in a pilot human randomized, controlled, cross over trial. Bone. 2021 Dec;153:116166. doi: 10.1016/j.bone.2021.116166. Epub 2021 Aug 28.
PubMed 34464780Lauritsen KM, Sondergaard E, Luong TV, Moller N, Gormsen LC. Acute Hyperketonemia Does Not Affect Glucose or Palmitate Uptake in Abdominal Organs or Skeletal Muscle. J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgaa122. doi: 10.1210/clinem/dgaa122.
PubMed 32161953Lauritsen KM, Sondergaard E, Svart M, Moller N, Gormsen LC. Ketone Body Infusion Increases Circulating Erythropoietin and Bone Marrow Glucose Uptake. Diabetes Care. 2018 Dec;41(12):e152-e154. doi: 10.2337/dc18-1421. Epub 2018 Oct 16. No abstract available.
PubMed 30327354
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ketone Bodies on Myocardial Glucose and Fatty Acid Metabolism in Healthy Volunteers: A Positron Emission Tomography Study
- ClinicalTrials.gov ID
- NCT02814474
- Acronym / sponsor ID
- 1-10-72-104-14
- Conditions
- Healthy Volunteers
- Keywords
- PET/CT, Heart failure, hydroxybutyrate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jun 2016 (estimated)
- 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.
Starvation and metabolic stress increase circulating ketone bodies, potentially providing the heart with an alternative oxidative fuel. Hyperketonemia reduces myocardial fatty acid consumption. It is unclear whether this is due to inhibited peripheral lipolysis or diminished uptake per se.
Aim: To test whether infusion of 3-hydroxybutyrate (BHB) inhibits myocardial glucose and fatty acid uptake.
Methods: Randomized, single blinded, cross-over interventional study in 8 healthy volunteers. Myocardial glucose and fatty acid metabolism studied by 11C-palmitate and 18F-FDG PET/CT. Experimental elevation of circulating ketone bodies by infusion of β-hydroxy-β-methylbutyrate.
Detailed description
Background:
Ketone bodies are produced by the liver in conditions of increased fatty acid oxidation, serving as important fuel sources during fasting and starvation. They are metabolized to acetyl-CoA which enters the tricarboxylic acid cycle, enabling ATP production independently of glycolysis and resulting in lower oxygen consumption per mole of produced ATP compared to glucose [ref]. Their primary physiological function appears to be as an alternative protein-sparing source of energy for extrahepatic tissues in times of reduced carbohydrate availability, preventing muscle wasting. The principal ketone bodies in humans are beta-hydroxybutyrate (BHB) and acetoacetate. Increased ketogenesis is a feature common to fasting, starvation and diabetes mellitus. Ketones have been shown to have a number of neuroprotective effects including anticonvulsant activity, improving cognitive function in Alzheimer's disease and decreasing the effects of acute brain injury and ischemic damage [ref], as well as antitumoral effect in gliomas. This has led to the suggestion that ketones could be used therapeutically for a number of diseases though currently the only recognized therapeutic use of ketones is in the form of ketogenic diets for the treatment of epilepsy.
There are limited in vivo studies on the effect of ketones on the heart. It is known that fatty acids are the preferred myocardial fuel substrate and that this shifts to increased use of glucose, and to a lesser extent ketones, in times of acutely increased demand. Interestingly, acute ketone infusion in pigs appears to inhibit myocardial fatty acid oxidation. In vitro studies suggest ketones decrease myocardial glucose uptake and affect myocardial contractility, with either increased or decreased contractility when ketones are the only energy source. This has not been further investigated in vivo. It is therefore unclear to what extent ketones can contribute to myocardial metabolism in conditions of hyperketonemia, and how this affects contractility.
The present project thus proposes to address the issues outlined above, by measuring human cerebral and cardiac uptake of energy substrates, together with functional parameters, using PET imaging and appropriate radiotracers, under experimental hyperketonemia.
Hypotheses:
- An acute increase in blood ketone concentration without previous ketoadaptation will decrease cardiac palmitate and glucose uptake in healthy humans.
Materials and methods
Effect of acute ketone infusion on cardiac perfusion and 18F-FDG and 11C-palmitate uptake in healthy subjects:
Study population: 10 healthy volunteers. All study subjects will be instructed to follow a standardised diet for 1 week before the study. On the study day, they will undergo a baseline dynamic cardiac PET scan with 15O-water followed by 11C-palmitate and 18F-FDG tracers, together with baseline blood samples, muscle biopsy and subcutaneous fat biopsy to assess peripheral metabolic status. An intravenous infusion of sodium betahydroxybutyrate will then be initiated at a concentration and rate sufficient to achieve 1-2 mM ketonemia after 30 minutes (assessed by blood sample). A second dynamic PET scan identical to the first will then be performed under continuous ketone infusion at a constant rate. Finally, a second set of blood samples, muscle and subcutaneous fat biopsies will be taken after the scan before stopping the ketone infusion.
Perspectives:
The results of this research are expected to provide insights into how human heart metabolism respond to increased ketone bodies, and whether there are significant functional improvements. It should contribute to further understanding the possible therapeutic benefits of both exogenous ketone administration and of fasting in relation to cardiac function, with implications for the treatment of various diseases such as diabetes and heart failure. Knowledge of ketones' effects on the kinetics of various radionuclide tracers also has importance for the appropriate clinical use of diagnostic PET scans in patients with elevated blood ketone levels. In addition, the implementation and validation of a ketone PET tracer will allow further future non-invasive studies that directly measure ketone metabolism in various tissues and disease states.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SALINE | Placebo comparator | Other: SalineInfusion of saline (0.9 %) |
| KETONE | Experimental | Other: Na-3-hydroxybutyrateInfusion of Na-3-Hydroxybutyrate (0.18 g/kg/hour) for 390 minutes |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (8 listed)
- Decreased cardiac function
- Kidney disease
- Pulmonary disease
- Current malignant disease
- Substance abuse
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 |
|---|---|---|
| Na-3-hydroxybutyrateInfusion of Na-3-hydroxybutyrate (0.18 g/kg/hour) for 390 minutes | Other | KETONE |
| SalineInfusion of 0.9 % saline | Other | SALINE |
Primary outcome
Myocardial Glucose uptake
Time frame: After 330 minutes of ketone infusion
Dynamic 18F-FDG PET/CT scan - 50 minutes
Myocardial Fatty Acid Metabolism
Time frame: After 210 minutes of ketone infusion
Dynamic 11C-palmitate PET/CT scan - 50 minutes
Myocardial Blood Flow
Time frame: After 180 minutes of ketone infusion
Dynamic 15O-H2O PET/CT scan - 6 minutes
1 secondary outcome
Insulin sensitivity
Time frame: Time 0-390 of the ketone body infusion
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 4 Jul 2016.
- Derived from this study: PubMed 34464780Svart M, Gormsen LC, Espersen R, Rittig N, Starup-Linde J, Moller N, Rejnmark L. 3-Hydroxybutyrate administration elevates plasma parathyroid hormone in a pilot human randomized, controlled, cross over trial. Bone. 2021 Dec;153:116166. doi: 10.1016/j.bone.2021.116166. Epub 2021 Aug 28.
- Derived from this study: PubMed 32161953Lauritsen KM, Sondergaard E, Luong TV, Moller N, Gormsen LC. Acute Hyperketonemia Does Not Affect Glucose or Palmitate Uptake in Abdominal Organs or Skeletal Muscle. J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgaa122. doi: 10.1210/clinem/dgaa122.
- Derived from this study: PubMed 30327354Lauritsen KM, Sondergaard E, Svart M, Moller N, Gormsen LC. Ketone Body Infusion Increases Circulating Erythropoietin and Bone Marrow Glucose Uptake. Diabetes Care. 2018 Dec;41(12):e152-e154. doi: 10.2337/dc18-1421. Epub 2018 Oct 16. No abstract available.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Niels Møller, MD DMsc study chair
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Na-3-hydroxybutyrate and Saline in people with Healthy Volunteers, run by University of Aarhus at 2 sites 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 1 inclusion and 8 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 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Myocardial Glucose uptake (time frame: After 330 minutes of ketone infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814474, which also lists 3 linked publications.
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 4 Jul 2016.