Overweight and ObesityNCT06368297
The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults
A study testing Ketone Monoester Supplementation and Ketogenic diet in people with Overweight and Obesity and Cognitive Change, run by University of Macau.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Cognitive Change, Psychophysiologic Reaction
- What is being tested?
- Ketone Monoester Supplementation and Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) > 25 and < 35 kg/m2 (overweight/obese group) or BMI > 18.5 and < 25 kg/m2 (healthy weight group);
- Right-handed.
Who cannot join
- Presenting any established counter indication for transcranial magnetic stimulation;
- Currently taking any medication affecting the central or the peripheral nervous system;
- Suffering from any psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus;
- Undertaking surgery in the past six months;
- Engaged in resistance training.
- Pregnancy;
- Breastfeeding;
- Being amenorrhea.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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)
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.
Read the detailed description
The study initially makes a bold attempt to explore whether the ketone supplementation would induce improvements in the overweight/ obese population's brain health via altering motor cortex plasticity, brain function and structure, and metabolic and neuroendocrine pathways. The study's aims include:
- assessing changes in brain plasticity associated with excessive body weight and/or obesity.
- evaluating the potential of ketone monoester supplementation in enhancing brain plasticity.
- evaluating the potential of ketone monoester supplementation in correcting impaired brain plasticity due to excessive body weight.
- evaluating the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity.
- investigating structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation.
- assessing the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation.
- Being tested
- Ketone Monoester Supplementation, Ketogenic diet
- Keywords
- Overweight, Obesity, Ketone, Neurocognition
- Medical subject headings
- Overweight, Obesity, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Monoester SupplementationDietary supplement
Exogenous ketones are a class of ketone bodies that are ingested using nutritional supplements or foods. This class of ketone bodies refers to the three water-soluble ketones (acetoacetate, β-hydroxybutyrate [β-HB], and acetone).
Ketogenic dietDietary supplement
The ketogenic diet typically reduces total carbohydrate intake to less than 50 grams a day-less than the amount found in a medium plain bagel-and can be as low as 20 grams a day. Generally, popular ketogenic resources suggest an average of 70-80% fat from total daily calories, 5-10% carbohydrate, and 10-20% protein.
| Study group | Role | What they receive |
|---|---|---|
| Acute effect of ketone monoester supplementation | Experimental | To investigate the acute effect of ketone monoester ingestion on brain cortical plasticity using high-frequency rTMS. Receives: Dietary Supplement: Ketone Monoester Supplementation |
| Effects of a 2-week ketogenic diet or ketone monoester supplementation | Experimental | To evaluate the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity.
To investigate structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation.
To assess the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation. Receives: Dietary Supplement: Ketone Monoester Supplementation; Dietary Supplement: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Plasticity
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 is typically in millivolts (mV) for the amplitude of the MEPs. MEPs are electrical signals recorded from muscles after stimulation of the motor cortex with TMS, reflecting the excitability of the corticospinal pathway and, indirectly, cortical plasticity.
Measured: 2 weeks
Grey Matter Volume
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 include areas dense with neuronal cell bodies, dendrites, axon terminals, and glial cells.
Measured: 2 weeks
Cortical Thickness
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, typically ranging from around 1 mm to 4 mm, depending on the specific brain region and individual differences.
Measured: 2 weeks
Blood-Oxygen-Level-Dependent (BOLD) Signal Changes
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 levels that occur in response to neural activity.
Measured: 2 weeks
Secondary outcomes (22)
Blood Glucose
The measurement name is "blood glucose". It will be assessed by a glucometer in laboratory settings. The unit of measurement is millimoles per liter (mmol/L).
Measured: 6 weeks
Blood Beta-Hydroxybutyrate
The measurement name is "blood beta-hydroxybutyrate". It will be assessed by specific ketone meters designed for beta-hydroxybutyrate measurement. The unit of measurement is millimoles per liter (mmol/L).
Measured: 6 weeks
Blood Insulin
The measurement name is "blood insulin". It will be assessed by immunoassay system (chemiluminescence immunoassay analyzer) using blood samples. The unit of measurement is microunits per milliliter (μU/mL).
Measured: 6 weeks
Leptin
The measurement name is "leptin". It will be assessed by immunoassay system (chemiluminescence immunoassay analyzer) using blood samples. The unit of measurement is nanograms per milliliter (ng/mL).
Measured: 6 weeks
Ghrelin
The measurement name is "ghrelin". It will be assessed by immunoassay system (chemiluminescence immunoassay analyzer) using blood samples. The unit of measurement is picograms per milliliter (pg/mL).
Measured: 6 weeks
Brain-Derived Neurotrophic Factor
The measurement name is "brain-derived neurotrophic factor". It will be assessed by immunoassay system (chemiluminescence immunoassay analyzer) using blood samples. The unit of measurement is nanograms per milliliter (ng/mL).
Measured: 6 weeks
Reaction Time of Attention Network Test
The measurement name is "reaction time of Attention Network Test". The measurement will be assessed by psychological paradigm named Attention Network Test. The unit of measurement is milliseconds (ms).
Measured: 2 weeks
Accuracy of Attention Network Test
The measurement name is "accuracy of attention network test". The measurement will be assessed by psychological paradigm named Attention Network Test. Accuracy is generally measured as a percentage (%).
Measured: 2 weeks
Reaction Time of Stroop Task
The measurement name is "reaction time of stroop task". The measurement will be assessed by psychological paradigm named Stroop Task. The unit of measurement is milliseconds (ms).
Measured: 2 weeks
Accuracy of Stroop Task
The measurement name is "accuracy of stroop task". The measurement will be assessed by psychological paradigm named Stroop Task. Accuracy is generally measured as a percentage (%).
Measured: 2 weeks
Reaction Time of N-back Task
The measurement name is "reaction time of n-back task". The measurement will be assessed by psychological paradigm named N-back task. The unit of measurement is milliseconds (ms).
Measured: 2 weeks
Accuracy of N-back Task
The measurement name is "accuracy of n-back task". The measurement will be assessed by psychological paradigm named N-back task. Accuracy is generally measured as a percentage (%).
Measured: 2 weeks
Cerebral Hemoglobin Concentration
The measurement name is "cerebral hemoglobin concentration". The measurement will be assessed by functional near-infrared spectroscopy (fNIRS). The unit of measurement is micromoles per liter (μM).
Measured: 2 weeks
Height in Kilograms
The measurement name is "height in kilograms". It will be assessed by a stadiometer. The unit of measurement is meters (m).
Measured: 2 weeks
Weight in Meters
The measurement name is "weight in meters". It will be assessed by a scale. The unit of measurement is kilograms (kg).
Measured: 2 weeks
Body Fat Percentage
The measurement name is "body fat percentage". It will be assessed by a bioelectrical impedance analysis device. The unit of measurement is percentage (%).
Measured: 2 weeks
Fat Mass
The measurement name is "fat mass". It will be assessed by a bioelectrical impedance analysis device. The unit of measurement is kilograms (kg).
Measured: 2 weeks
Muscle Mass
The measurement name is "muscle mass". It will be assessed by a bioelectrical impedance analysis device. The unit of measurement is kilograms (kg).
Measured: 2 weeks
Body Water
The measurement name is "body water". It will be assessed by a bioelectrical impedance analysis device. The unit of measurement is liters (L).
Measured: 2 weeks
Body Mass Index
The measurement name is "body mass index (BMI)". It will be assessed by calculating BMI using height and weight measurements obtained from a stadiometer and a scale, respectively. The unit of measurement is kilograms per square meter (kg/m²).
Measured: 2 weeks
Skinfold Thickness
The measurement name is "skinfold thickness". It will be assessed by skinfold calipers. The unit of measurement is millimeters (mm).
Measured: 2 weeks
Maximal Oxygen Uptake
The measurement name is "maximal oxygen uptake". It will be assessed by cardiopulmonary exercise testing (CPET) equipment, such as cycle ergometers, along with a metabolic cart for measuring oxygen consumption. The unit of measurement is milliliters of oxygen per kilogram per minute (mL/kg/min).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Macau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaowei Kong, PhD, Principal investigator, University of Macau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368297
- Sponsor's protocol ID
- BSERE22-APP007-FED
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared by request two years after the completion. The data will be available for two years.
Publications
Falkenhain K, Daraei A, Forbes SC, Little JP. Effects of Exogenous Ketone Supplementation on Blood Glucose: A Systematic Review and Meta-analysis. Adv Nutr. 2022 Oct 2;13(5):1697-1714. doi: 10.1093/advances/nmac036.
PubMed 35380602Evans M, McClure TS, Koutnik AP, Egan B. Exogenous Ketone Supplements in Athletic Contexts: Past, Present, and Future. Sports Med. 2022 Dec;52(Suppl 1):25-67. doi: 10.1007/s40279-022-01756-2. Epub 2022 Oct 10.
PubMed 36214993Kesl SL, Poff AM, Ward NP, Fiorelli TN, Ari C, Van Putten AJ, Sherwood JW, Arnold P, D'Agostino DP. Effects of exogenous ketone supplementation on blood ketone, glucose, triglyceride, and lipoprotein levels in Sprague-Dawley rats. Nutr Metab (Lond). 2016 Feb 4;13:9. doi: 10.1186/s12986-016-0069-y. eCollection 2016.
PubMed 26855664Walsh JJ, Neudorf H, Little JP. 14-Day Ketone Supplementation Lowers Glucose and Improves Vascular Function in Obesity: A Randomized Crossover Trial. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1738-e1754. doi: 10.1210/clinem/dgaa925.
PubMed 33367782Yu Q, Wong KK, Lei OK, Armada-da-Silva PAS, Wu Z, Nie J, Shi Q, Kong Z. Acute ketone monoester supplementation in young adults: modulating metabolic and neurocognitive functions across body weights. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-12. doi: 10.1139/apnm-2024-0229. Epub 2024 Oct 17.
PubMed 39418669
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06368297
- Acronym / sponsor ID
- BSERE22-APP007-FED
- Keywords
- Overweight, Obesity, Ketone, Neurocognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MacauUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study initially makes a bold attempt to explore whether the ketone supplementation would induce improvements in the overweight/ obese population's brain health via altering motor cortex plasticity, brain function and structure, and metabolic and neuroendocrine pathways. The study's aims include:
- assessing changes in brain plasticity associated with excessive body weight and/or obesity.
- evaluating the potential of ketone monoester supplementation in enhancing brain plasticity.
- evaluating the potential of ketone monoester supplementation in correcting impaired brain plasticity due to excessive body weight.
- evaluating the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity.
- investigating structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation.
- assessing the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute effect of ketone monoester supplementation | Experimental | Dietary Supplement: Ketone Monoester SupplementationTo investigate the acute effect of ketone monoester ingestion on brain cortical plasticity using high-frequency rTMS. |
| Effects of a 2-week ketogenic diet or ketone monoester supplementation | Experimental | Dietary Supplement: Ketone Monoester Supplementation, Dietary Supplement: Ketogenic dietTo evaluate the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity. To investigate structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation. To assess the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) > 25 and < 35 kg/m2 (overweight/obese group) or BMI > 18.5 and < 25 kg/m2 (healthy weight group);
- Right-handed.
Key exclusion criteria (8 listed)
- Presenting any established counter indication for transcranial magnetic stimulation;
- Currently taking any medication affecting the central or the peripheral nervous system;
- Suffering from any psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus;
- Undertaking surgery in the past six months;
- Engaged in resistance training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone Monoester SupplementationExogenous ketones are a class of ketone bodies that are ingested using nutritional supplements or foods. This class of ketone bodies refers to the three water-soluble ketones (acetoacetate, β-hydroxybutyrate [β-HB], and acetone). | Dietary supplement | Acute effect of ketone monoester supplementation, Effects of a 2-week ketogenic diet or ketone monoester supplementation |
| Ketogenic dietThe ketogenic diet typically reduces total carbohydrate intake to less than 50 grams a day-less than the amount found in a medium plain bagel-and can be as low as 20 grams a day. Generally, popular ketogenic resources suggest an average of 70-80% fat from total daily calories, 5-10% carbohydrate, and 10-20% protein. | Dietary supplement | Effects of a 2-week ketogenic diet or ketone monoester supplementation |
Primary outcome
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 is typically in millivolts (mV) for the amplitude of the MEPs. MEPs are electrical signals recorded from muscles after stimulation of the motor cortex with TMS, reflecting the excitability of the corticospinal pathway and, indirectly, cortical plasticity.
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 include areas dense with neuronal cell bodies, dendrites, axon terminals, and glial cells.
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, typically ranging from around 1 mm to 4 mm, depending on the specific brain region and individual differences.
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 levels that occur in response to neural activity.
22 secondary outcomes
Blood Glucose
Time frame: 6 weeks
Blood Beta-Hydroxybutyrate
Time frame: 6 weeks
Blood Insulin
Time frame: 6 weeks
Leptin
Time frame: 6 weeks
Ghrelin
Time frame: 6 weeks
Brain-Derived Neurotrophic Factor
Time frame: 6 weeks
Reaction Time of Attention Network Test
Time frame: 2 weeks
Accuracy of Attention Network Test
Time frame: 2 weeks
Reaction Time of Stroop Task
Time frame: 2 weeks
Accuracy of Stroop Task
Time frame: 2 weeks
Reaction Time of N-back Task
Time frame: 2 weeks
Accuracy of N-back Task
Time frame: 2 weeks
Cerebral Hemoglobin Concentration
Time frame: 2 weeks
Height in Kilograms
Time frame: 2 weeks
Weight in Meters
Time frame: 2 weeks
Body Fat Percentage
Time frame: 2 weeks
Fat Mass
Time frame: 2 weeks
Muscle Mass
Time frame: 2 weeks
Body Water
Time frame: 2 weeks
Body Mass Index
Time frame: 2 weeks
Skinfold Thickness
Time frame: 2 weeks
Maximal Oxygen Uptake
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 35380602Falkenhain K, Daraei A, Forbes SC, Little JP. Effects of Exogenous Ketone Supplementation on Blood Glucose: A Systematic Review and Meta-analysis. Adv Nutr. 2022 Oct 2;13(5):1697-1714. doi: 10.1093/advances/nmac036.
- Background: PubMed 36214993Evans M, McClure TS, Koutnik AP, Egan B. Exogenous Ketone Supplements in Athletic Contexts: Past, Present, and Future. Sports Med. 2022 Dec;52(Suppl 1):25-67. doi: 10.1007/s40279-022-01756-2. Epub 2022 Oct 10.
- Results publication: PubMed 26855664Kesl SL, Poff AM, Ward NP, Fiorelli TN, Ari C, Van Putten AJ, Sherwood JW, Arnold P, D'Agostino DP. Effects of exogenous ketone supplementation on blood ketone, glucose, triglyceride, and lipoprotein levels in Sprague-Dawley rats. Nutr Metab (Lond). 2016 Feb 4;13:9. doi: 10.1186/s12986-016-0069-y. eCollection 2016.
- Results publication: PubMed 33367782Walsh JJ, Neudorf H, Little JP. 14-Day Ketone Supplementation Lowers Glucose and Improves Vascular Function in Obesity: A Randomized Crossover Trial. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1738-e1754. doi: 10.1210/clinem/dgaa925.
- Derived from this study: PubMed 39418669Yu Q, Wong KK, Lei OK, Armada-da-Silva PAS, Wu Z, Nie J, Shi Q, Kong Z. Acute ketone monoester supplementation in young adults: modulating metabolic and neurocognitive functions across body weights. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-12. doi: 10.1139/apnm-2024-0229. Epub 2024 Oct 17.
- Individual participant dataSharing planned: Yes. The data will be shared by request two years after the completion. The data will be available for two years.
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaowei Kong, PhD principal investigator
University of Macau
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Monoester Supplementation and Ketogenic diet in people with Overweight and Obesity and Cognitive Change, run by University of Macau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaowei Kong, PhD (8822 8730 ext. 853, zwkong@um.edu.mo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Plasticity (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368297, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.