Acute Effects of Exercise Combined With Ketone Ester Supplement

April 10, 2024 updated by: University of Macau

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • body mass index > 25 kg∙m-2;
  • right-handed.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIIE-KT condition
High-intensity interval exercise (HIIE) with ketone supplements [R-1,3-butanediol; HVMN, Inc., San Francisco, CA, USA].
Other: Ketone monoester supplementation
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).
Other: High-intensity interval exercise
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 (Monark 839E, Sweden).
Experimental: MICE-KT condition
moderate-intensity continuous exercise (MICE) with ketone supplements.
Other: Ketone monoester supplementation
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).
Other: Moderate-intensity continuous exercise
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 (Monark 839E, Sweden).
Experimental: NE-KT condition
Non-exercise with ketone supplements.
Other: Ketone monoester supplementation
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).
Experimental: HIIE-PLA condition
HIIE with taste-matched placebo
Other: High-intensity interval exercise
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 (Monark 839E, Sweden).
Other: Placebo
The placebo will be the taste-matched water.
Experimental: MICE-PLA condition
MICE with taste-matched placebo
Other: Moderate-intensity continuous exercise
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 (Monark 839E, Sweden).
Other: Placebo
The placebo will be the taste-matched water.
Experimental: NE-PLA condition
Non-exercise with taste-matched placebo
Other: Placebo
The placebo will be the taste-matched water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 weeks
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).
6 weeks
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).
6 weeks
Blood Lipid
Time Frame: 6 weeks
The measurement name is "blood lipid". It will be assessed by the Cholestech LDX™ System in laboratory settings. The unit of measurement is milligrams per deciliter (mg/dL).
6 weeks
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).
6 weeks
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).
6 weeks
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).
6 weeks
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).
6 weeks
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).
6 weeks
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 (%).
6 weeks
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).
6 weeks
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 (%).
6 weeks
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).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arousal Level
Time Frame: 6 weeks
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).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Macau

Investigators

  • Principal Investigator: Zhaowei Kong, PhD, University of Macau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSERE24-APP001-FED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared 2 years after completion. The data will be available for 2 years.

IPD Sharing Time Frame

01/04/2025 - 01/04/2027

IPD Sharing Access Criteria

Acquire by request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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