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CompletedNCT02814474Updated Jul 4, 2016

Effects of Experimental Hyperketonemia on Myocardial Metabolism

An Early Phase 1 interventional study of Na-3-hydroxybutyrate and Saline in Healthy Volunteers, sponsored by University of Aarhus. Completed at 2 sites in Denmark. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-04.

Sponsored by University of Aarhus · Early Phase 1, Interventional, and Basic science

Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Study 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.

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:

  1. 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • PET/CT
  • Heart failure
  • hydroxybutyrate
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Placebo comparator
    SALINE

    Infusion of saline (0.9 %)

    Other: Saline

  • Experimental
    KETONE

    Infusion of Na-3-Hydroxybutyrate (0.18 g/kg/hour) for 390 minutes

    Other: Na-3-hydroxybutyrate

Interventions

  • OtherNa-3-hydroxybutyrate

    Infusion of Na-3-hydroxybutyrate (0.18 g/kg/hour) for 390 minutes

  • OtherSaline

    Infusion of 0.9 % saline

06

What researchers measure

Primary outcomes

  1. Myocardial Glucose uptake

    Dynamic 18F-FDG PET/CT scan - 50 minutes

    Time frame: After 330 minutes of ketone infusion

  2. Myocardial Fatty Acid Metabolism

    Dynamic 11C-palmitate PET/CT scan - 50 minutes

    Time frame: After 210 minutes of ketone infusion

  3. Myocardial Blood Flow

    Dynamic 15O-H2O PET/CT scan - 6 minutes

    Time frame: 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

    Time frame: Time 0-390 of the ketone body infusion

07

Study locations

2 sites
  • Department of Nuclear Medicine & PET Center, Aarhus University Hospital
    Aarhus, 8000, Denmark
  • Medical Research Laboratories
    Aarhus, 8000, Denmark
08

References and documents

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 34464780 ↗
  • Lauritsen 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 32161953 ↗
  • Lauritsen 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02814474
Lead sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
Responsible party
Sponsor
First posted
Jun 27, 2016
Start date
Oct 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jul 4, 2016

Study contacts

Niels Møller, MD DMsc
study chair · Aarhus University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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