Motor Cortex Plasticity Response to Theta-Burst Stimulation After Ketone Monoester Supplementation
NCT ID: NCT06799260
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-12-18
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
The study protocol involves two interventions administered sequentially during each visit:
Supplement intervention (KME/placebo) followed after one hour by a stimulation intervention (iTBS/cTBS).
There will be two separate groups of subjects undergoing different TBS protocols (iTBS vs cTBS).
The subjects of each group will crossover the supplement intervention (KME and placebo) in two visits separated by one week.
BASIC_SCIENCE
DOUBLE
Study Groups
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KME then placebo supplement with iTBS stimulation
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
Ketone Monoester (KME)
500 mg/kg body weight of the KME supplement
Placebo
Taste-matched placebo drink
iTBS
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).
Placebo then KME supplement with iTBS stimulation
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
Ketone Monoester (KME)
500 mg/kg body weight of the KME supplement
Placebo
Taste-matched placebo drink
iTBS
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).
KME then placebo supplement with cTBS stimulation
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
Ketone Monoester (KME)
500 mg/kg body weight of the KME supplement
Placebo
Taste-matched placebo drink
cTBS
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).
Placebo then KME supplement with cTBS stimulation
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
Ketone Monoester (KME)
500 mg/kg body weight of the KME supplement
Placebo
Taste-matched placebo drink
cTBS
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).
Interventions
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Ketone Monoester (KME)
500 mg/kg body weight of the KME supplement
Placebo
Taste-matched placebo drink
iTBS
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
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).
Eligibility Criteria
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Inclusion Criteria
* Right-handed
* Fully vaccinated against COVID-19
Exclusion Criteria
* Highly active subjects (athletes)
* Obese (BMI ≥ 30 kg/m2)
* Smokers
* Following intermittent fasting or ketogenic diet
* Long COVID-19
18 Years
35 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Universiti Putra Malaysia
OTHER
Responsible Party
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Wan Aliaa Wan Sulaiman
Associate Professor
Principal Investigators
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Wan Aliaa Wan Sulaiman, FRCP
Role: STUDY_CHAIR
Universiti Putra Malaysia
Locations
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Hospital Sultan Abdul Aziz Shah
Serdang, Selangor, Malaysia
Countries
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Other Identifiers
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FRGS/1/2022/SKK01/UPM/02/4
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
JKEUPM-2021-485
Identifier Type: -
Identifier Source: org_study_id
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