Effects of Ketone Bodies on Insulin Sensitivity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Growth Hormone, Human, Oral ketone supplement (KetoAid®, KE4), Saline infusion (placebo), Oral placebo drink.
- Who it may be relevant to
- Registry conditions: Insulin Resistance, Obesity & Overweight, Energy Metabolism, Ketone Body Metabolism. Basic parameters: 55 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
KETO-SENSE - Effects of Ketone Bodies on Insulin Sensitivity
Overview
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.
Interventions
- Drug Growth Hormone, Human
Continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) for approximately 7 hours to induce physiological lipolysis. - Dietary supplement Oral ketone supplement (KetoAid®, KE4)
Oral administration of D-β-hydroxybutyrate ester (R-1,3-butanediol β-hydroxybutyrate). - Drug Saline infusion (placebo)
Continuous IV infusion of isotonic saline as placebo for growth hormone. - Dietary supplement Oral placebo drink
Oral administration of an isocaloric placebo drink.
Primary outcome measures
- 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]
- Tissue-specific uptake of β-hydroxybutyrate and palmitate measured by PET/CT imaging [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Tissue-specific oxidation of β-hydroxybutyrate and palmitate measured by PET/CT imaging [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Energy expenditure [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Cardiac output measured by PET/CT imaging [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Myocardial glucose and fatty acid uptake rates [Time frame: During four experimental study days conducted over approximately 12 weeks]
Secondary outcome measures (9)
- Skeletal muscle pyruvate dehydrogenase (PDHa) enzymatic activity [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Adipose tissue lipoprotein lipase (LPL) enzymatic activity [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Expression levels of lipolytic regulatory proteins in adipose tissue [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Phosphorylation levels of insulin-regulated proteins in skeletal muscle [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Expression levels of insulin-regulated proteins in skeletal muscle [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Expression levels of GH-regulated proteins (GHR, JAK2, STAT5, BCL6) in skeletal muscle and adipose tissue [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Relative mRNA expression of GH-responsive genes (SOCS1-3, CISH, IGF-I) in skeletal muscle and adipose tissue [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Skeletal muscle mitochondrial oxidative phosphorylation capacity [Time frame: During four experimental study days conducted over approximately 12 weeks]
- Muscle glycogen content [Time frame: During four experimental study days conducted over approximately 12 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Aarhus University Hospital — Aarhus N
Identifiers
NCT: NCT07359625 · KETO-SENSE