Acute Effects of Exercise Combined With Ketone Ester Supplement

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-04-30

Brief Summary

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To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults.

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Detailed Description

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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

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Overweight and Obesity Cognitive Change Ketoses, Metabolic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) condition

High-intensity interval exercise (HIIE) with ketone supplements \[R-1,3-butanediol; San Francisco\].

Group Type EXPERIMENTAL

Ketone monoester supplementation

Intervention Type OTHER

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

Intervention Type OTHER

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.

MICE-KT condition

moderate-intensity continuous exercise (MICE) with ketone supplements.

Group Type EXPERIMENTAL

Ketone monoester supplementation

Intervention Type OTHER

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).

Moderate-intensity continuous exercise

Intervention Type OTHER

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.

Nonexercise (NE)-KT condition

Non-exercise with ketone supplements.

Group Type EXPERIMENTAL

Ketone monoester supplementation

Intervention Type OTHER

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).

HIIE-Placebo (PLA) condition

HIIE with taste-matched placebo

Group Type EXPERIMENTAL

High-intensity interval exercise

Intervention Type OTHER

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.

Placebo

Intervention Type OTHER

The placebo will be the taste-matched water.

MICE-PLA condition

MICE with taste-matched placebo

Group Type EXPERIMENTAL

Moderate-intensity continuous exercise

Intervention Type OTHER

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.

Placebo

Intervention Type OTHER

The placebo will be the taste-matched water.

NE-PLA condition

Non-exercise with taste-matched placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type OTHER

The placebo will be the taste-matched water.

Interventions

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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, and acetone).

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Placebo

The placebo will be the taste-matched water.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes