Overweight and ObesityNCT06365957
Acute Effects of Exercise Combined With Ketone Ester Supplement
A study testing Ketone monoester supplementation, High-intensity interval exercise and Moderate-intensity continuous exercise in people with Overweight and Obesity and Cognitive Change, run by University of Macau.
Trial summary
To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Cognitive Change, Ketoses, Metabolic
- What is being tested?
- Ketone monoester supplementation, High-intensity interval exercise and Moderate-intensity continuous exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2025
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index > 25 kg/m^2;
- right-handed.
Who cannot join
- psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus;
- addicts to alcohol, nicotine, or drugs;
- oral contraceptive or any medication intake during the past 6 months;
- current engagement in any resistant exercise.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Acute Changes in Cardiometabolic and Neurocognitive Outcomes in Response to Exercise Combined With Ketone Ester Supplement in Overweight/Obese Adults
To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults.
Read the detailed description
The prevalence of excess body weight and associated medical burdens (i.e., cardiometabolic and neurocognitive impairments) have been rising over the past several decades globally. The combination of exercise and ketone supplementation has been recently proposed as one of the solutions with potential clinical value, of which the interventional effects and underlying mechanisms remain unclear. The current study aims at (1) investigating the additive effects of ketone ester supplements to exercise in aspects of cardiorespiratory fitness, metabolism, and neurocognitive status, and (2) examining how the exercise type (HIIE [high-intensity interval exercise] vs. MICE [moderate-intensity continuous exercise]) influences the cardiometabolic and neurocognitive responses of the exercise-diet regime. For each of the 30 participants, six experimental trials will be performed in a randomized trial with a counterbalanced order: (1) HIIE-KT condition (HIIE with ketone supplements); (2) MICE-KT condition (MICE with ketone supplements); (3) NE-KT condition (non-exercise with ketone supplements); (4) HIIE-PLA condition (HIIE with taste-matched placebo); (5) MICE-PLA condition; and (6) NE-PLA condition. Cardiometabolic and neurocognitive parameters will be assessed before and after 30, 60, and 90 min subsequently ketone ester supplements.
- Conditions
- Overweight and Obesity, Cognitive Change, Ketoses, Metabolic
- Being tested
- Ketone monoester supplementation, High-intensity interval exercise, Moderate-intensity continuous exercise, Placebo
- Keywords
- Overweight, Obesity, Exercise, Nutrients, Neurocognition, Metabolism
- Medical subject headings
- Overweight, Obesity, Ketosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone monoester supplementationOther
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, and acetone).
High-intensity interval exerciseOther
High-intensity interval exercise is a type of interval training exercise. It incorporates several rounds that alternate between several minutes of high-intensity movements to significantly increase the heart rate to at least 80% of one's maximum heart rate, followed by short periods of lower-intensity movements. The exercise will be conducted on a computer-monitored cycle ergometer.
Moderate-intensity continuous exerciseOther
Moderate-intensity continuous exercise generally consists of 30-60 min of aerobic exercise at 64-76% peak heart rate, while interval training involves more intense bouts interspersed by recovery periods. The exercise will be conducted on a computer-monitored cycle ergometer.
PlaceboOther
The placebo will be the taste-matched water.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) condition | Experimental | High-intensity interval exercise (HIIE) with ketone supplements [R-1,3-butanediol; San Francisco]. Receives: Other: Ketone monoester supplementation; Other: High-intensity interval exercise |
| MICE-KT condition | Experimental | moderate-intensity continuous exercise (MICE) with ketone supplements. Receives: Other: Ketone monoester supplementation; Other: Moderate-intensity continuous exercise |
| Nonexercise (NE)-KT condition | Experimental | Non-exercise with ketone supplements. Receives: Other: Ketone monoester supplementation |
| HIIE-Placebo (PLA) condition | Experimental | HIIE with taste-matched placebo Receives: Other: High-intensity interval exercise; Other: Placebo |
| MICE-PLA condition | Experimental | MICE with taste-matched placebo Receives: Other: Moderate-intensity continuous exercise; Other: Placebo |
| NE-PLA condition | Experimental | Non-exercise with taste-matched placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Systolic Blood Pressure
The measurement name is "systolic blood pressure". It will be assessed by a blood pressure monitor in laboratory settings. The unit of measurement is millimeters of mercury (mmHg).
Measured: 6 weeks
Diastolic Blood Pressure
The measurement name is "diastolic blood pressure". It will be assessed by a blood pressure monitor in laboratory settings. The unit of measurement is millimeters of mercury (mmHg).
Measured: 6 weeks
Concentration of Blood Lipid
The measurement name is "blood lipid". It will be assessed by the cholestene system in laboratory settings. The unit of measurement is milligrams per deciliter (mg/dL).
Measured: 6 weeks
Concentration of 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
Concentration of 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
Concentration of Blood Lactic Acid
The measurement name is "blood lactic acid". It will be assessed by lactate monitor in laboratory settings. The unit of measurement is millimoles per litre (mmol/L).
Measured: 6 weeks
Concentration of 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
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: 6 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: 6 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: 6 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: 6 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: 6 weeks
Secondary outcomes (1)
Arousal Level
The measurement name is "arousal level". It will be assessed by the Two-Dimensional Mood Scale in laboratory settings. The level is scored 0-5 (no special unit).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT06365957
- Sponsor's protocol ID
- BSERE24-APP001-FED
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 22 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 2 years after completion. The data will be available for 2 years.
Publications
Walsh JJ, Caldwell HG, Neudorf H, Ainslie PN, Little JP. Short-term ketone monoester supplementation improves cerebral blood flow and cognition in obesity: A randomized cross-over trial. J Physiol. 2021 Nov;599(21):4763-4778. doi: 10.1113/JP281988. Epub 2021 Oct 4.
PubMed 34605026Margolis LM, O'Fallon KS. Utility of Ketone Supplementation to Enhance Physical Performance: A Systematic Review. Adv Nutr. 2020 Mar 1;11(2):412-419. doi: 10.1093/advances/nmz104.
PubMed 31586177Valenzuela PL, Castillo-Garcia A, Morales JS, Lucia A. Perspective: Ketone Supplementation in Sports-Does It Work? Adv Nutr. 2021 Mar 31;12(2):305-315. doi: 10.1093/advances/nmaa130.
PubMed 33094332Kesl 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 26855664Zhang Y, Kuang Y, LaManna JC, Puchowicz MA. Contribution of brain glucose and ketone bodies to oxidative metabolism. Adv Exp Med Biol. 2013;765:365-370. doi: 10.1007/978-1-4614-4989-8_51.
PubMed 22879057
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Changes in Cardiometabolic and Neurocognitive Outcomes in Response to Exercise Combined With Ketone Ester Supplement in Overweight/Obese Adults
- ClinicalTrials.gov ID
- NCT06365957
- Acronym / sponsor ID
- BSERE24-APP001-FED
- Conditions
- Overweight and Obesity, Cognitive Change, Ketoses, Metabolic
- Keywords
- Overweight, Obesity, Exercise, Nutrients, Neurocognition, Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MacauUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 15 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.
To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults.
Detailed description
The prevalence of excess body weight and associated medical burdens (i.e., cardiometabolic and neurocognitive impairments) have been rising over the past several decades globally. The combination of exercise and ketone supplementation has been recently proposed as one of the solutions with potential clinical value, of which the interventional effects and underlying mechanisms remain unclear. The current study aims at (1) investigating the additive effects of ketone ester supplements to exercise in aspects of cardiorespiratory fitness, metabolism, and neurocognitive status, and (2) examining how the exercise type (HIIE [high-intensity interval exercise] vs. MICE [moderate-intensity continuous exercise]) influences the cardiometabolic and neurocognitive responses of the exercise-diet regime. For each of the 30 participants, six experimental trials will be performed in a randomized trial with a counterbalanced order: (1) HIIE-KT condition (HIIE with ketone supplements); (2) MICE-KT condition (MICE with ketone supplements); (3) NE-KT condition (non-exercise with ketone supplements); (4) HIIE-PLA condition (HIIE with taste-matched placebo); (5) MICE-PLA condition; and (6) NE-PLA condition. Cardiometabolic and neurocognitive parameters will be assessed before and after 30, 60, and 90 min subsequently ketone ester supplements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) condition | Experimental | Other: Ketone monoester supplementation, Other: High-intensity interval exerciseHigh-intensity interval exercise (HIIE) with ketone supplements [R-1,3-butanediol; San Francisco]. |
| MICE-KT condition | Experimental | Other: Ketone monoester supplementation, Other: Moderate-intensity continuous exercisemoderate-intensity continuous exercise (MICE) with ketone supplements. |
| Nonexercise (NE)-KT condition | Experimental | Other: Ketone monoester supplementationNon-exercise with ketone supplements. |
| HIIE-Placebo (PLA) condition | Experimental | Other: High-intensity interval exercise, Other: PlaceboHIIE with taste-matched placebo |
| MICE-PLA condition | Experimental | Other: Moderate-intensity continuous exercise, Other: PlaceboMICE with taste-matched placebo |
| NE-PLA condition | Experimental | Other: PlaceboNon-exercise with taste-matched placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- body mass index > 25 kg/m^2;
- right-handed.
Key exclusion criteria (4 listed)
- psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus;
- addicts to alcohol, nicotine, or drugs;
- oral contraceptive or any medication intake during the past 6 months;
- current engagement in any resistant exercise.
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, and acetone). | Other | High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) condition, MICE-KT condition, Nonexercise (NE)-KT condition |
| High-intensity interval exerciseHigh-intensity interval exercise is a type of interval training exercise. It incorporates several rounds that alternate between several minutes of high-intensity movements to significantly increase the heart rate to at least 80% of one's maximum heart rate, followed by short periods of lower-intensity movements. The exercise will be conducted on a computer-monitored cycle ergometer. | Other | HIIE-Placebo (PLA) condition, High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) condition |
| Moderate-intensity continuous exerciseModerate-intensity continuous exercise generally consists of 30-60 min of aerobic exercise at 64-76% peak heart rate, while interval training involves more intense bouts interspersed by recovery periods. The exercise will be conducted on a computer-monitored cycle ergometer. | Other | MICE-KT condition, MICE-PLA condition |
| PlaceboThe placebo will be the taste-matched water. | Other | HIIE-Placebo (PLA) condition, MICE-PLA condition, NE-PLA condition |
Primary outcome
Maximal Oxygen Uptake
Time frame: 2 weeks
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).
Systolic Blood Pressure
Time frame: 6 weeks
The measurement name is "systolic blood pressure". It will be assessed by a blood pressure monitor in laboratory settings. The unit of measurement is millimeters of mercury (mmHg).
Diastolic Blood Pressure
Time frame: 6 weeks
The measurement name is "diastolic blood pressure". It will be assessed by a blood pressure monitor in laboratory settings. The unit of measurement is millimeters of mercury (mmHg).
Concentration of Blood Lipid
Time frame: 6 weeks
The measurement name is "blood lipid". It will be assessed by the cholestene system in laboratory settings. The unit of measurement is milligrams per deciliter (mg/dL).
Concentration of Blood Glucose
Time frame: 6 weeks
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).
Concentration of Blood Beta-Hydroxybutyrate
Time frame: 6 weeks
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).
Concentration of Blood Lactic Acid
Time frame: 6 weeks
The measurement name is "blood lactic acid". It will be assessed by lactate monitor in laboratory settings. The unit of measurement is millimoles per litre (mmol/L).
Concentration of Blood Insulin
Time frame: 6 weeks
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).
Reaction Time of Stroop Task
Time frame: 6 weeks
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).
Accuracy of Stroop Task
Time frame: 6 weeks
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 (%).
Reaction Time of N-back Task
Time frame: 6 weeks
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).
Accuracy of N-back Task
Time frame: 6 weeks
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 (%).
Cerebral Hemoglobin Concentration
Time frame: 6 weeks
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).
1 secondary outcome
Arousal Level
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 34605026Walsh JJ, Caldwell HG, Neudorf H, Ainslie PN, Little JP. Short-term ketone monoester supplementation improves cerebral blood flow and cognition in obesity: A randomized cross-over trial. J Physiol. 2021 Nov;599(21):4763-4778. doi: 10.1113/JP281988. Epub 2021 Oct 4.
- Background: PubMed 31586177Margolis LM, O'Fallon KS. Utility of Ketone Supplementation to Enhance Physical Performance: A Systematic Review. Adv Nutr. 2020 Mar 1;11(2):412-419. doi: 10.1093/advances/nmz104.
- Background: PubMed 33094332Valenzuela PL, Castillo-Garcia A, Morales JS, Lucia A. Perspective: Ketone Supplementation in Sports-Does It Work? Adv Nutr. 2021 Mar 31;12(2):305-315. doi: 10.1093/advances/nmaa130.
- Background: 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.
- Background: PubMed 22879057Zhang Y, Kuang Y, LaManna JC, Puchowicz MA. Contribution of brain glucose and ketone bodies to oxidative metabolism. Adv Exp Med Biol. 2013;765:365-370. doi: 10.1007/978-1-4614-4989-8_51.
- Individual participant dataSharing planned: Yes. The data will be shared 2 years after completion. The data will be available for 2 years.
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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, High-intensity interval exercise and Moderate-intensity continuous exercise 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 4 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 22 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?
Maximal Oxygen Uptake (time frame: 2 weeks). The study lists 13 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 NCT06365957, 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 22 Apr 2024.