Clinical trial

Effects of Ketone Bodies on Insulin Sensitivity

Recruiting now · Not applicable · 1 countries · Registry ID NCT07359625

Recruiting nowNot applicableInterventional

What this study is about

KETO-SENSE is a clinical research study investigating how ketone bodies affect energy metabolism and insulin sensitivity in humans. Ketone bodies are naturally produced by the liver during fasting or prolonged exercise and can serve as an alternative fuel for the brain, heart, and muscles. In this study, ten overweight but otherwise healthy adults aged 55-70 years will participate in four study days at Aarhus University Hospital. Participants will receive one of four interventions in a randomized crossover design: 1) growth hormone (GH) and a ketone supplement, 2) GH and placebo, 3) a saline infusion with the ketone supplement, or 4) placebo (saline infusion and placebo supplement). The study uses advanced PET/CT imaging, indirect calorimetry, and tissue biopsies to measure how ketones influence fat breakdown, glucose uptake, and energy expenditure. By understanding these mechanisms, the study aims to clarify whether oral ketone supplementation can improve insulin sensitivity and energy metabolism - findings that could be relevant for common conditions such as overweight, insulin resistance, and type 2 diabetes.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age55 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionInsulin Resistance, Obesity & Overweight, Energy Metabolism, Ketone Body Metabolism

Full registry criteria

Inclusion Criteria: * Age range: 55-70 yr * BMI: 25 - 35 kg/m2 Exclusion Criteria: \- Any evidence of acute or chronic illnesses, apart from well-controlled hypertension, that is judged by the investigators to impact the study

Treatments and study arms

Growth Hormone, Human

Drug

Continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) for approximately 7 hours to induce physiological lipolysis.

Oral ketone supplement (KetoAid®, KE4)

Dietary Supplement

Oral administration of D-β-hydroxybutyrate ester (R-1,3-butanediol β-hydroxybutyrate).

Saline infusion (placebo)

Drug

Continuous IV infusion of isotonic saline as placebo for growth hormone.

Oral placebo drink

Dietary Supplement

Oral administration of an isocaloric placebo drink.

Primary outcomes

Insulin-stimulated glucose uptake in skeletal muscle and organs measured by [¹⁸F]-FDG PETDuring four experimental study days conducted over approximately 12 weeks

Quantification of insulin-stimulated glucose uptake rates in skeletal muscle and selected organs using dynamic \[¹⁸F\]-FDG PET during a hyperinsulinemic-euglycemic clamp to assess insulin sensitivity.

Tissue-specific uptake of β-hydroxybutyrate and palmitate measured by PET/CT imagingDuring four experimental study days conducted over approximately 12 weeks

Quantification of tissue-specific uptake of β-hydroxybutyrate (BHB) and palmitate in skeletal muscle, adipose tissue, and myocardium using dynamic PET/CT imaging with \[¹¹C\]-OHB and \[¹¹C\]-palmitate tracers.

Tissue-specific oxidation of β-hydroxybutyrate and palmitate measured by PET/CT imagingDuring four experimental study days conducted over approximately 12 weeks

Quantification of oxidation rates of β-hydroxybutyrate (BHB) and palmitate in skeletal muscle, adipose tissue, and myocardium using dynamic PET/CT imaging with \[¹¹C\]-OHB and \[¹¹C\]-palmitate tracers to assess tissue-specific substrate utilization.

Energy expenditureDuring four experimental study days conducted over approximately 12 weeks

Measurement of resting and insulin-stimulated energy expenditure using indirect calorimetry and analysis of respiratory exchange ratio (RER).

Cardiac output measured by PET/CT imagingDuring four experimental study days conducted over approximately 12 weeks

Quantification of cardiac output in the basal state and during the hyperinsulinemic-euglycemic clamp using dynamic PET/CT imaging to evaluate hemodynamic effects of GH and β-hydroxybutyrate.

Myocardial glucose and fatty acid uptake ratesDuring four experimental study days conducted over approximately 12 weeks

Assessment of myocardial substrate metabolism using dynamic PET/CT imaging with \[¹⁸F\]-FDG and \[¹¹C\]-palmitate tracers during the basal period and the hyperinsulinemic-euglycemic clamp to quantify myocardial utilization of glucose and fatty acids.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Aarhus University Hospital🇩🇰 Aarhus N, Denmark

Open map

Simon Bøggild Hansen, MDContact

Email · Call +45 4111 1574