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Recruiting NCT07359625

NCT07359625 Effects of Ketone Bodies on Insulin Sensitivity

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Clinical Trial Summary
NCT ID NCT07359625
Status Recruiting
Phase
Sponsor University of Aarhus
Condition Insulin Resistance
Study Type INTERVENTIONAL
Enrollment 10 participants
Start Date 2025-12-02
Primary Completion 2027-04

Eligibility & Interventions

Sex All sexes
Min Age 55 Years
Max Age 70 Years
Study Type INTERVENTIONAL
Interventions
Growth Hormone, HumanOral ketone supplement (KetoAid®, KE4)Saline infusion (placebo)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 10 participants in total. It began in 2025-12-02 with a primary completion date of 2027-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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

Contact & Investigator

Central Contact

Simon Bøggild Hansen, MD

✉ simhan@clin.au.dk

📞 +45 4111 1574

Frequently Asked Questions

Who can join the NCT07359625 clinical trial?

This trial is open to participants of all sexes, aged 55 Years or older, up to 70 Years, studying Insulin Resistance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07359625 currently recruiting?

Yes, NCT07359625 is actively recruiting participants. Contact the research team at simhan@clin.au.dk for enrollment information.

Where is the NCT07359625 trial being conducted?

This trial is being conducted at Aarhus N, Denmark.

Who is sponsoring the NCT07359625 clinical trial?

NCT07359625 is sponsored by University of Aarhus. The trial plans to enroll 10 participants.

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