MedPath

Acute Effects of Exercise Combined With Ketone Ester Supplement

Not Applicable
Not yet recruiting
Conditions
Cognitive Change
Ketoses, Metabolic
Overweight and Obesity
Interventions
Other: Placebo
Other: Ketone monoester supplementation
Other: High-intensity interval exercise
Other: Moderate-intensity continuous exercise
Registration Number
NCT06365957
Lead Sponsor
University of Macau
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
20
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
MICE-KT conditionModerate-intensity continuous exercisemoderate-intensity continuous exercise (MICE) with ketone supplements.
NE-PLA conditionPlaceboNon-exercise with taste-matched placebo
MICE-KT conditionKetone monoester supplementationmoderate-intensity continuous exercise (MICE) with ketone supplements.
HIIE-Placebo (PLA) conditionHigh-intensity interval exerciseHIIE with taste-matched placebo
HIIE-Placebo (PLA) conditionPlaceboHIIE with taste-matched placebo
MICE-PLA conditionModerate-intensity continuous exerciseMICE with taste-matched placebo
Nonexercise (NE)-KT conditionKetone monoester supplementationNon-exercise with ketone supplements.
High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) conditionHigh-intensity interval exerciseHigh-intensity interval exercise (HIIE) with ketone supplements \[R-1,3-butanediol; San Francisco\].
High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) conditionKetone monoester supplementationHigh-intensity interval exercise (HIIE) with ketone supplements \[R-1,3-butanediol; San Francisco\].
MICE-PLA conditionPlaceboMICE with taste-matched placebo
Primary Outcome Measures
NameTimeMethod
Diastolic Blood Pressure6 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).

Systolic Blood Pressure6 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).

Accuracy of N-back Task6 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 (%).

Concentration of Blood Glucose6 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).

Reaction Time of N-back Task6 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).

Cerebral Hemoglobin Concentration6 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).

Concentration of Blood Lipid6 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 Beta-Hydroxybutyrate6 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 Acid6 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 Insulin6 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).

Maximal Oxygen Uptake2 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).

Reaction Time of Stroop Task6 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 Task6 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 (%).

Secondary Outcome Measures
NameTimeMethod
Arousal Level6 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).

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