NCT06368297

The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults: A Neurophysiological and Resting Functional Magnetic Resonance Study (rfMRI)

Status unknown NA Last updated 10 April 2024

What this trial tests

NA trial testing Ketone Monoester Supplementation in Overweight and Obesity in 40 participants. Status unknown.

Timeline

1 April 2024

Primary endpoint
1 August 2024

1 August 2024

Quick facts

Lead sponsor	University of Macau
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	40
Start date	1 April 2024
Primary completion	1 August 2024
Estimated completion	1 August 2024

Drugs / interventions tested

• Ketone Monoester Supplementation
• Ketogenic diet — full drug profile →

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →
• Cognitive Change — all drugs for Cognitive Change →
• Psychophysiologic Reaction — all drugs for Psychophysiologic Reaction →

Sponsor

University of Macau

Who can join

Adults 20 to 50, any sex, with Overweight and Obesity or Cognitive Change. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Brain Plasticity
  Time frame: 2 weeks
  This measurement is "brain plasticity". Brain plasticity, also known as neuroplasticity, refers to the brain's remarkable ability to change and adapt in response to experience. The brain plasticity will be measured by transcranial magnetic stimulation (TMS) system. When assessing brain plasticity using TMS through the measurement of Motor Evoked Potentials (MEPs), the primary unit of measurement i
• Grey Matter Volume
  Time frame: 2 weeks
  The measurement name is "grey matter volume", which belongs to brain structure. The grey matter volume will be assessed by the magnetic resonance imaging system. Grey matter volume is generally measured in cubic centimeters (cm³) or milliliters (mL), as both units are equivalent in volume measurement (1 cm³ = 1 mL). This measure reflects the volume of grey matter regions in the brain, which includ
• Cortical Thickness
  Time frame: 2 weeks
  The measurement name is "cortical thickness", which belongs to brain structure. The cortical thickness will be assessed by the magnetic resonance imaging system. Cortical thickness is measured in millimeters (mm). It refers to the average thickness of the grey matter cortex across various regions of the brain. Cortical thickness can vary significantly across different parts of the cortex, typicall
• Blood-Oxygen-Level-Dependent (BOLD) Signal Changes
  Time frame: 2 weeks
  The measurement name is "Blood-Oxygen-Level-Dependent (BOLD) Signal Changes", which belongs to brain function. The cortical thickness will be assessed by the magnetic resonance imaging system (MRI). The unit of BOLD signal changes measured by MRI is typically expressed as a percentage change (%). The BOLD signal reflects changes in the magnetic properties of blood due to variations in oxygenation

Sponsor's own description

This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Acute ketone monoester supplementation in young adults: modulating metabolic and neurocognitive functions across body weights.
   Yu Q, Wong KK, Lei OK, Armada-da-Silva PAS, et al · · 2025 · cited 1× · PMID 39418669 · DOI 10.1139/apnm-2024-0229