Effects of Ketone Bodies on Insulin Sensitivity (KETO-SENSE)

University of Aarhus

Status: Enrolling

Conditions: Ketone Body Metabolism; Energy Metabolism; Obesity & Overweight; Insulin Resistance

Treatments: Dietary Supplement: Oral placebo drink; Dietary Supplement: Oral ketone supplement (KetoAid®, KE4); Drug: Saline infusion (placebo); Drug: Growth Hormone, Human

Study type: Interventional

Funder types: Other

Identifiers

NCT07359625

KETO-SENSE

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 55 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

10 participants in 4 patient groups, including a placebo group

GH infusion + oral ketone supplement

Experimental group

Description:

Participants receive a continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) combined with oral ketone supplementation.

Treatment:

Drug: Growth Hormone, Human

Dietary Supplement: Oral ketone supplement (KetoAid®, KE4)

GH infusion + oral placebo

Experimental group

Description:

Participants receive a continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) combined with oral placebo

Treatment:

Drug: Growth Hormone, Human

Dietary Supplement: Oral placebo drink

Saline infusion + oral ketone supplement

Experimental group

Description:

Participants receive an intravenous saline infusion combined with oral ketone supplementation.

Treatment:

Drug: Saline infusion (placebo)

Dietary Supplement: Oral ketone supplement (KetoAid®, KE4)

Saline infusion + oral placebo

Placebo Comparator group

Description:

Participants receive a continuous intravenous infusion of saline combined with oral placebo

Treatment:

Drug: Saline infusion (placebo)

Dietary Supplement: Oral placebo drink