RecruitingNot ApplicableNCT07359625

Effects of Ketone Bodies on Insulin Sensitivity

KETO-SENSE - Effects of Ketone Bodies on Insulin Sensitivity


Sponsor

University of Aarhus

Enrollment

10 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 55 YearsMax Age: 70 Years

Inclusion Criteria2

  • Age range: 55-70 yr
  • BMI: 25 - 35 kg/m2

Exclusion Criteria1

  • \- Any evidence of acute or chronic illnesses, apart from well-controlled hypertension, that is judged by the investigators to impact the study

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Interventions

DRUGGrowth Hormone, Human

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

DIETARY_SUPPLEMENTOral ketone supplement (KetoAid®, KE4)

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

DRUGSaline infusion (placebo)

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

DIETARY_SUPPLEMENTOral placebo drink

Oral administration of an isocaloric placebo drink.


Locations(1)

Aarhus University Hospital

Aarhus N, Denmark

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NCT07359625


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