An interventional study of Ketone Monoester (KME) and Placebo in Healthy Young Adult and Neurophysiology, sponsored by Universiti Putra Malaysia. Active, not recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Basic science
Transcranial magnetic stimulation is a medical device that can alter motor cortical (M1) excitability through the scalp via various protocols. Among these, intermittent- and continuous-theta burst stimulation (iTBS/cTBS) are increasingly used protocols to enhance or suppress M1 excitability, respectively, beyond stimulation. However, the poor reproducibility and high inter-individual variability in responses to TBS protocols are matters of concern. This study will explore whether ketone monoester supplementation can boost TBS efficacy via their mechanistic convergence on Brain-Derived Neurotrophic Factor (BDNF).
Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.
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KME drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with iTBS stimulation over the left M1 hand region
Dietary Supplement: Ketone Monoester (KME) · Dietary Supplement: Placebo · Device: iTBS
Placebo drink with iTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with iTBS stimulation over the left M1 hand region
Dietary Supplement: Ketone Monoester (KME) · Dietary Supplement: Placebo · Device: iTBS
KME drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a placebo drink with cTBS stimulation over the left M1 hand region
Dietary Supplement: Ketone Monoester (KME) · Dietary Supplement: Placebo · Device: cTBS
Placebo drink with cTBS stimulation over the left M1 hand region, followed after a 1-week washout period by a KME drink with cTBS stimulation over the left M1 hand region
Dietary Supplement: Ketone Monoester (KME) · Dietary Supplement: Placebo · Device: cTBS
500 mg/kg body weight of the KME supplement
Taste-matched placebo drink
iTBS stimulation will be applied using a butterfly figure-of-eight Cool-B70 coil connected to a MagPro R30 stimulator with add-on Theta Burst option (MagVenture A/S, Farum, Denmark).
cTBS stimulation will be applied using a butterfly figure-of-eight Cool-B70 coil connected to a MagPro R30 stimulator with add-on Theta Burst option (MagVenture A/S, Farum, Denmark).
Motor evoked potential (MEP)
Peak-to-peak MEP amplitude elicited by single-pulse TMS over the left M1 representation of the first dorsal interosseous (FDI) muscle. In each MEP measurement, 12 MEP readings will be collected, elicited by single-pulse TMS at an intensity of 120% resting motor threshold and separated by 15 seconds. In each timepoint post-TBS, the mean value of MEPs (aka, conditioned MEPs) will be averaged and compared to pre-TBS (aka, baseline MEPs) using the following equation: (conditioned MEP amplitude/baseline MEP amplitude) × 100. A value of 90-110 represents no change, while values \< 90% represent suppression and \> 110% facilitation of the M1 plasticity following TBS.
Time frame: Pre-TBS (baseline) and post-TBS at 0, 5, 10, 20, and 30 minutes.
TMSens_Q questionnaire
Self-reported side effects using the TMSens\_Q questionnaire to evaluate the tolerability of the KME-TBS combination.
Time frame: At 30 minutes post-TBS stimulation
Corticospinal excitability indices
Resting motor threshold (RMT) followed by motor-evoked potential at 120% RMT intensity
Time frame: Pre-KME supplementation and at 1 hour post-KME supplementation
Blood pressure
Systolic blood pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Arterial Pressure (MAP) using fully automated oscillometric sphygmomanometer
Time frame: Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and serially thereafter every 3-5 minutes until 30 minutes post-TBS
Heart rate
Heart rate (bpm) using pulse oximeter
Time frame: Pre-supplementation, at 1 hour post-supplementation/pre-TBS stimulation, and continuously thereafter for 30 minutes post-TBS
Blood glucose
On-site using a portable glucometer
Time frame: Pre-KME supplementation and at 30 minutes post-TBS stimulation
Blood beta-hydroxybutyrate
On-site using a portable glucometer
Time frame: Pre-KME supplementation and at 30 minutes post-TBS stimulation
Serum brain-derived neurotrophic factor
Serum levels of mature brain-derived neurotrophic factor (mBDNF) and pro-BDNF isoforms
Time frame: Pre-KME supplementation and at 30 minutes post-TBS stimulation
BDNF genetic polymorphism
BDNF rs6265 single nucleotide polymorphism
Time frame: At the baseline (pre-KME supplementation)
Plan to share: Yes — Deidentified raw datasets collected during the trial will be freely available upon completion on the Open Science Framework repository at https://osf.io/
No publications or documents are linked to this record.
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Universiti Putra Malaysia