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Effects of Ketone Bodies on Insulin Sensitivity

NCT07359625 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07359625 on ClinicalTrials.gov