Acute Effects of Exercise Combined With Ketone Ester Supplement

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06365957
• Other study ID #: BSERE24-APP001-FED
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: University of Macau
• Contact: Zhaowei Kong, PhD
• Phone: 8822 8730
• Email: zwkong[@]um.edu.mo
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change
• Ketoses, Metabolic
• Ketosis
• Overweight
• Overweight and Obesity

Intervention

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, ß-hydroxybutyrate, and acetone).
• 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.
• 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.
• Placebo
The placebo will be the taste-matched water.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Macau

References & Publications (5)

Kesl SL, Poff AM, Ward NP, Fiorelli TN, Ari C, Van Putten AJ, Sherwood JW, Arnold P, D'Agostino DP. Effects of exogenous ketone supplementation on blood ketone, glucose, triglyceride, and lipoprotein levels in Sprague-Dawley rats. Nutr Metab (Lond). 2016 Feb 4;13:9. doi: 10.1186/s12986-016-0069-y. eCollection 2016. — View Citation

Margolis LM, O'Fallon KS. Utility of Ketone Supplementation to Enhance Physical Performance: A Systematic Review. Adv Nutr. 2020 Mar 1;11(2):412-419. doi: 10.1093/advances/nmz104. — View Citation

Valenzuela PL, Castillo-Garcia A, Morales JS, Lucia A. Perspective: Ketone Supplementation in Sports-Does It Work? Adv Nutr. 2021 Mar 31;12(2):305-315. doi: 10.1093/advances/nmaa130. — View Citation

Walsh JJ, Caldwell HG, Neudorf H, Ainslie PN, Little JP. Short-term ketone monoester supplementation improves cerebral blood flow and cognition in obesity: A randomized cross-over trial. J Physiol. 2021 Nov;599(21):4763-4778. doi: 10.1113/JP281988. Epub 2021 Oct 4. — View Citation

Zhang Y, Kuang Y, LaManna JC, Puchowicz MA. Contribution of brain glucose and ketone bodies to oxidative metabolism. Adv Exp Med Biol. 2013;765:365-370. doi: 10.1007/978-1-4614-4989-8_51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Oxygen Uptake	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
Primary	Systolic Blood Pressure	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
Primary	Diastolic Blood Pressure	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
Primary	Concentration of Blood Lipid	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).	6 weeks
Primary	Concentration of Blood Glucose	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
Primary	Concentration of Blood Beta-Hydroxybutyrate	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
Primary	Concentration of Blood Lactic Acid	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
Primary	Concentration of Blood Insulin	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
Primary	Reaction Time of Stroop Task	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
Primary	Accuracy of Stroop Task	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
Primary	Reaction Time of N-back Task	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
Primary	Accuracy of N-back Task	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
Primary	Cerebral Hemoglobin Concentration	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	Arousal Level	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