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Acute Effects of Exercise Combined With Ketone Ester Supplement

Acute Changes in Cardiometabolic and Neurocognitive Outcomes in Response to Exercise Combined With Ketone Ester Supplement in Overweight/Obese Adults

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06365957
Enrollment
20
Registered
2024-04-15
Start date
2024-04-30
Completion date
2025-04-30
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Cognitive Change, Ketoses, Metabolic

Keywords

Overweight, Obesity, Exercise, Nutrients, Neurocognition, Metabolism

Brief summary

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.

Interventions

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 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 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.

OTHERPlacebo

The placebo will be the taste-matched water.

Sponsors

University of Macau
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Hemoglobin Concentration6 weeksThe 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).
Maximal Oxygen Uptake2 weeksThe 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 Pressure6 weeksThe 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 Pressure6 weeksThe 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 Lipid6 weeksThe 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 Glucose6 weeksThe 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-Hydroxybutyrate6 weeksThe 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 Acid6 weeksThe 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 Insulin6 weeksThe 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 Task6 weeksThe 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 Task6 weeksThe 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 Task6 weeksThe 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 Task6 weeksThe 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 (%).

Secondary

MeasureTime frameDescription
Arousal Level6 weeksThe 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).

Contacts

Primary ContactZhaowei Kong, PhD
zwkong@um.edu.mo8822 8730
Backup ContactZhen Yuan, PhD
zhenyuan@um.edu.mo8822 2314

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026