Effects of Ketone Bodies on Insulin Sensitivity

Sponsor
University of Aarhus
Study ID
NCT07359625
Status
Recruiting
Apply to this trial

Conditions

  • Energy Metabolism
  • Insulin Resistance
  • Ketone Body Metabolism
  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
55 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jan 22, 2026
Start date
Dec 2, 2025
Status verified
Dec 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: GH infusion + oral ketone supplement
    Participants receive a continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) combined with oral ketone supplementation.
  • Experimental: GH infusion + oral placebo
    Participants receive a continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) combined with oral placebo
  • Experimental: Saline infusion + oral ketone supplement
    Participants receive an intravenous saline infusion combined with oral ketone supplementation.
  • Placebo Comparator: Saline infusion + oral placebo
    Participants receive a continuous intravenous infusion of saline combined with oral placebo

Primary Outcome Measure

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

Central Contacts

Related Studies