Trials / Completed
CompletedNCT06395051
Effects of Ketone Monoesters on Brain Function
Acute Effects of Ketone Monoester Supplementation on Brain Function in Older Men with Overweight
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Maastricht University Medical Center · Academic / Other
- Sex
- Male
- Age
- 60 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
Disturbances in brain insulin-sensitivity are not only observed in obesity and type 2 diabetes (T2D), but also during brain aging and in dementia. Ketone monoester supplements may improve brain insulin-sensitivity, which can be quantified by measuring the gray-matter cerebral blood flow (CBF) response to intranasally administered insulin. We hypothesize that acute ketone monoester supplementation increases (regional) brain vascular function and insulin-sensitivity thereby improving cognitive performance and appetite control. The primary objective is to evaluate in older men the acute effect of ketone monoester supplementation on (regional) brain vascular function and insulin-sensitivity, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). The CBF response to intranasal insulin is a robust and sensitive physiological marker of brain insulin-sensitivity. Secondary objectives are to investigate effects on cognitive performance as assessed with a neuropsychological test battery, and appetite control as quantified by functional MRI (fMRI) with visual food cues.
Conditions
- Brain Insulin Sensitivity
- Brain Vascular Function
- Cerebral Blood Flow
- Cognitive Performance
- Appetite Control
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Ketone Monoester | Ketone monoester supplement (395 mg/kg body mass) |
| DIETARY_SUPPLEMENT | Placebo | The placebo will be taste-matched to the active supplement for bitterness using denatonium benzoate and volume-matched with water |
Timeline
- Start date
- 2024-07-03
- Primary completion
- 2024-11-15
- Completion
- 2024-11-15
- First posted
- 2024-05-01
- Last updated
- 2025-02-20
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06395051. Inclusion in this directory is not an endorsement.