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Effects of Ketone Monoesters on Brain Function

NCT06395051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Peter J Joris, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2024-11-15
Completion
2024-11-15

Countries

  • Netherlands

Study Locations

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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 NCT06395051 on ClinicalTrials.gov