Clinical trial NCT06365957: Acute Effects of Exercise Combined With Ketone Ester Supplement
Official title: Acute Changes in Cardiometabolic and Neurocognitive Outcomes in Response to Exercise Combined With Ketone Ester Supplement in Overweight/Obese Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Cognitive Change
Ketoses, Metabolic
Keywords: Overweight
Obesity
Exercise
Nutrients
Neurocognition
Metabolism
Lead sponsor: University of Macau
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximal Oxygen Uptake
timeFrame: 2 weeks
measure: Systolic Blood Pressure
timeFrame: 6 weeks
measure: Diastolic Blood Pressure
timeFrame: 6 weeks
measure: Concentration of Blood Lipid
timeFrame: 6 weeks
measure: Concentration of Blood Glucose
timeFrame: 6 weeks
measure: Concentration of Blood Beta-Hydroxybutyrate
timeFrame: 6 weeks
measure: Concentration of Blood Lactic Acid
timeFrame: 6 weeks
measure: Concentration of Blood Insulin
timeFrame: 6 weeks
measure: Reaction Time of Stroop Task
timeFrame: 6 weeks
measure: Accuracy of Stroop Task
timeFrame: 6 weeks
measure: Reaction Time of N-back Task
timeFrame: 6 weeks
measure: Accuracy of N-back Task
timeFrame: 6 weeks
measure: Cerebral Hemoglobin Concentration
timeFrame: 6 weeks
Secondary outcomes:
measure: Arousal Level
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Macau
name: Zhaowei Kong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.