Acute Effects of Exercise Combined With Ketone Ester Supplement

NCT06365957 | Not Yet Recruiting DMC

• 1 other identifier: BSERE24-APP001-FED
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity; Cognitive Change; Ketoses, Metabolic

Keywords

Overweight; Obesity; Exercise; Nutrients; Neurocognition; Metabolism

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Arousal Level

  6 weeks

Study Arms (6)

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

EXPERIMENTAL

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

Other: Ketone monoester supplementation; Other: High-intensity interval exercise

MICE-KT condition

EXPERIMENTAL

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

Other: Ketone monoester supplementation; Other: Moderate-intensity continuous exercise

Nonexercise (NE)-KT condition

EXPERIMENTAL

Non-exercise with ketone supplements.

Other: Ketone monoester supplementation

HIIE-Placebo (PLA) condition

EXPERIMENTAL

HIIE with taste-matched placebo

Other: High-intensity interval exercise; Other: Placebo

MICE-PLA condition

EXPERIMENTAL

MICE with taste-matched placebo

Other: Moderate-intensity continuous exercise; Other: Placebo

NE-PLA condition

EXPERIMENTAL

Non-exercise with taste-matched placebo

Other: Placebo

Interventions

Ketone monoester supplementation 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 (HIIE)-Ketone Supplementation (KT) condition; MICE-KT condition; Nonexercise (NE)-KT condition

High-intensity interval exercise 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.

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

Moderate-intensity continuous exercise 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.

MICE-KT condition; MICE-PLA condition

Placebo OTHER

The placebo will be the taste-matched water.

HIIE-Placebo (PLA) condition; MICE-PLA condition; NE-PLA condition

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index \> 25 kg/m\^2;
• right-handed.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Macau: lead

Related Publications (5)

• 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.

  PMID: 34605026 BACKGROUND

• 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.

  PMID: 31586177 BACKGROUND

• 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.

  PMID: 33094332 BACKGROUND

• 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.

  PMID: 26855664 BACKGROUND

• 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.

  PMID: 22879057 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Ketosis; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zhaowei Kong, PhD

  University of Macau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaowei Kong, PhD

CONTACT

8822 8730; zwkong@um.edu.mo

Zhen Yuan, PhD

CONTACT

8822 2314; zhenyuan@um.edu.mo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 01/04/2025 - 01/04/2027
• Access Criteria: Acquire by request.