Motor Cortex Plasticity Response to Theta-Burst Stimulation After Ketone Monoester Supplementation (KME-TBS)

University of Putra Malaysia (UPM)

Status: Enrolling

Conditions: Healthy Young Adult; Neurophysiology

Treatments: Device: iTBS; Dietary Supplement: Placebo; Device: cTBS; Dietary Supplement: Ketone Monoester (KME)

Study type: Interventional

Funder types: Other

Identifiers

NCT06799260

JKEUPM-2021-485

FRGS/1/2022/SKK01/UPM/02/4 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy young adults (18-35 years old)
• Right-handed
• Fully vaccinated against COVID-19

Exclusion criteria

• Subjects with contraindications to TMS based on the screening 13-item questionnaire for TMS safety
• Highly active subjects (athletes)
• Obese (BMI ≥ 30 kg/m2)
• Smokers
• Following intermittent fasting or ketogenic diet
• Long COVID-19

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 4 patient groups

KME then placebo supplement with iTBS stimulation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ketone Monoester (KME)

Dietary Supplement: Placebo

Device: iTBS

Placebo then KME supplement with iTBS stimulation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ketone Monoester (KME)

Dietary Supplement: Placebo

Device: iTBS

KME then placebo supplement with cTBS stimulation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ketone Monoester (KME)

Device: cTBS

Dietary Supplement: Placebo

Placebo then KME supplement with cTBS stimulation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ketone Monoester (KME)

Device: cTBS

Dietary Supplement: Placebo