Insulin ResistanceKETO-SENSENCT07359625
Effects of Ketone Bodies on Insulin Sensitivity
A study testing Growth Hormone, Human and Oral ketone supplement (KetoAid®, KE4) in people with Insulin Resistance and Obesity & Overweight, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity & Overweight, Energy Metabolism
- What is being tested?
- Growth Hormone, Human and Oral ketone supplement (KetoAid®, KE4)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Dec 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range: 55-70 yr
- BMI: 25 - 35 kg/m2
Who cannot join
- Any evidence of acute or chronic illnesses, apart from well-controlled hypertension, that is judged by the investigators to impact the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Simon Bøggild Hansen, MD, +45 4111 1574, simhan@clin.au.dk
About this study
Official title: KETO-SENSE - Effects of Ketone Bodies on Insulin Sensitivity
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.
- Being tested
- Growth Hormone, Human, Oral ketone supplement (KetoAid®, KE4), Saline infusion (placebo), Oral placebo drink
- Keywords
- insulin resistance, Overweight, Growth hormone, Ketone bodies, Lipolysis, Energy metabolism
- Medical subject headings
- Insulin Resistance, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Hormone, HumanDrug
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 drinkDietary supplement
Oral administration of an isocaloric placebo drink.
| Study group | Role | What they receive |
|---|---|---|
| GH infusion + oral ketone supplement | Experimental | Participants receive a continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) combined with oral ketone supplementation. Receives: Drug: Growth Hormone, Human; Dietary Supplement: Oral ketone supplement (KetoAid®, KE4) |
| GH infusion + oral placebo | Experimental | Participants receive a continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) combined with oral placebo Receives: Drug: Growth Hormone, Human; Dietary Supplement: Oral placebo drink |
| Saline infusion + oral ketone supplement | Experimental | Participants receive an intravenous saline infusion combined with oral ketone supplementation. Receives: Dietary Supplement: Oral ketone supplement (KetoAid®, KE4); Drug: Saline infusion (placebo) |
| Saline infusion + oral placebo | Placebo comparator | Participants receive a continuous intravenous infusion of saline combined with oral placebo Receives: Drug: Saline infusion (placebo); Dietary Supplement: Oral placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin-stimulated glucose uptake in skeletal muscle and organs measured by [¹⁸F]-FDG PET
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.
Measured: During four experimental study days conducted over approximately 12 weeks
Tissue-specific uptake of β-hydroxybutyrate and palmitate measured by PET/CT imaging
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.
Measured: During four experimental study days conducted over approximately 12 weeks
Tissue-specific oxidation of β-hydroxybutyrate and palmitate measured by PET/CT imaging
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.
Measured: During four experimental study days conducted over approximately 12 weeks
Energy expenditure
Measurement of resting and insulin-stimulated energy expenditure using indirect calorimetry and analysis of respiratory exchange ratio (RER).
Measured: During four experimental study days conducted over approximately 12 weeks
Cardiac output measured by PET/CT imaging
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.
Measured: During four experimental study days conducted over approximately 12 weeks
Myocardial glucose and fatty acid uptake rates
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.
Measured: During four experimental study days conducted over approximately 12 weeks
Secondary outcomes (9)
Skeletal muscle pyruvate dehydrogenase (PDHa) enzymatic activity
Assessment of skeletal-muscle PDHa enzymatic activity determined from the rate of acetyl-CoA production using a radioactivity-based assay and normalized to creatine content in the muscle homogenate.
Measured: During four experimental study days conducted over approximately 12 weeks
Adipose tissue lipoprotein lipase (LPL) enzymatic activity
Determination of heparin-releasable LPL activity in subcutaneous adipose-tissue and muscle biopsies using the glycerol-stabilized method to evaluate triglyceride-derived fatty-acid uptake.
Measured: During four experimental study days conducted over approximately 12 weeks
Expression levels of lipolytic regulatory proteins in adipose tissue
Expression of regulators of lipolysis to assess GH- and BHB-mediated effects on lipid metabolism.
Measured: During four experimental study days conducted over approximately 12 weeks
Phosphorylation levels of insulin-regulated proteins in skeletal muscle
Quantification of phosphorylation levels of insulin-regulated proteins in skeletal-muscle biopsies.
Measured: During four experimental study days conducted over approximately 12 weeks
Expression levels of insulin-regulated proteins in skeletal muscle
Quantification of protein expression levels of insulin-regulated proteins in skeletal-muscle biopsies.
Measured: 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
Quantification of GH-regulated proteins (GHR, JAK2, STAT5, BCL6) in muscle and adipose biopsies using capillary electrophoresis immunoassay for each intervention condition.
Measured: 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
Quantification of GH-responsive gene expression (SOCS1-3, CISH, IGF-I) in muscle and adipose biopsies using RT-PCR. Relative mRNA expression will be reported as fold change for each intervention condition.
Measured: During four experimental study days conducted over approximately 12 weeks
Skeletal muscle mitochondrial oxidative phosphorylation capacity
Assessment of mitochondrial oxidative phosphorylation capacity in permeabilized muscle fibers obtained from vastus lateralis biopsies, measured by high-resolution respirometry (Oroboros Oxygraph-2k).
Measured: During four experimental study days conducted over approximately 12 weeks
Muscle glycogen content
Measurement of skeletal-muscle glycogen stores to assess substrate utilization and glucose storage during growth-hormone and ketone interventions.
Measured: During four experimental study days conducted over approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start2 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359625
- Sponsor's protocol ID
- KETO-SENSE
- Acronym
- KETO-SENSE
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the small sample size, risk of indirect participant identification, and national data protection regulations (GDPR and Danish Data Protection Act). Aggregated and anonymized summary data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KETO-SENSE - Effects of Ketone Bodies on Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT07359625
- Acronym / sponsor ID
- KETO-SENSE / KETO-SENSE
- Keywords
- insulin resistance, Overweight, Growth hormone, Ketone bodies, Lipolysis, Energy metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GH infusion + oral ketone supplement | Experimental | Drug: Growth Hormone, Human, Dietary Supplement: Oral ketone supplement (KetoAid®, KE4)Participants receive a continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) combined with oral ketone supplementation. |
| GH infusion + oral placebo | Experimental | Drug: Growth Hormone, Human, Dietary Supplement: Oral placebo drinkParticipants receive a continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) combined with oral placebo |
| Saline infusion + oral ketone supplement | Experimental | Dietary Supplement: Oral ketone supplement (KetoAid®, KE4), Drug: Saline infusion (placebo)Participants receive an intravenous saline infusion combined with oral ketone supplementation. |
| Saline infusion + oral placebo | Placebo comparator | Drug: Saline infusion (placebo), Dietary Supplement: Oral placebo drinkParticipants receive a continuous intravenous infusion of saline combined with oral placebo |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age range: 55-70 yr
- BMI: 25 - 35 kg/m2
Key exclusion criteria (1 listed)
- Any evidence of acute or chronic illnesses, apart from well-controlled hypertension, that is judged by the investigators to impact the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth Hormone, HumanContinuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) for approximately 7 hours to induce physiological lipolysis. | Drug | GH infusion + oral ketone supplement, GH infusion + oral placebo |
| Oral ketone supplement (KetoAid®, KE4)Oral administration of D-β-hydroxybutyrate ester (R-1,3-butanediol β-hydroxybutyrate). | Dietary supplement | GH infusion + oral ketone supplement, Saline infusion + oral ketone supplement |
| Saline infusion (placebo)Continuous IV infusion of isotonic saline as placebo for growth hormone. | Drug | Saline infusion + oral ketone supplement, Saline infusion + oral placebo |
| Oral placebo drinkOral administration of an isocaloric placebo drink. | Dietary supplement | GH infusion + oral placebo, Saline infusion + oral placebo |
Primary outcome
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
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 imaging
Time frame: During 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 imaging
Time frame: During 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 expenditure
Time frame: During 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 imaging
Time frame: During 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 rates
Time frame: During 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the small sample size, risk of indirect participant identification, and national data protection regulations (GDPR and Danish Data Protection Act). Aggregated and anonymized summary data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Hormone, Human and Oral ketone supplement (KetoAid®, KE4) in people with Insulin Resistance and Obesity & Overweight, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Bøggild Hansen, MD (+45 4111 1574, simhan@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.