Acute Changes in Cardiometabolic and Neurocognitive Outcomes in Response to Exercise Combined With Ketone Ester Supplement in Overweight/Obese Adults
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Macau
- Enrollment
- 20
- Primary Endpoint
- Diastolic Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) condition
High-intensity interval exercise (HIIE) with ketone supplements [R-1,3-butanediol; San Francisco].
Intervention: Ketone monoester supplementation (Other)
High-intensity interval exercise (HIIE)-Ketone Supplementation (KT) condition
High-intensity interval exercise (HIIE) with ketone supplements [R-1,3-butanediol; San Francisco].
Intervention: High-intensity interval exercise (Other)
MICE-KT condition
moderate-intensity continuous exercise (MICE) with ketone supplements.
Intervention: Ketone monoester supplementation (Other)
MICE-KT condition
moderate-intensity continuous exercise (MICE) with ketone supplements.
Intervention: Moderate-intensity continuous exercise (Other)
Nonexercise (NE)-KT condition
Non-exercise with ketone supplements.
Intervention: Ketone monoester supplementation (Other)
HIIE-Placebo (PLA) condition
HIIE with taste-matched placebo
Intervention: High-intensity interval exercise (Other)
HIIE-Placebo (PLA) condition
HIIE with taste-matched placebo
Intervention: Placebo (Other)
MICE-PLA condition
MICE with taste-matched placebo
Intervention: Moderate-intensity continuous exercise (Other)
MICE-PLA condition
MICE with taste-matched placebo
Intervention: Placebo (Other)
NE-PLA condition
Non-exercise with taste-matched placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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).
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).
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 (%).
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).
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).
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).
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).
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 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 (%).
Secondary Outcomes
- Arousal Level(6 weeks)