Acute Effects of Exercise Combined With Ketone Ester Supplement

University of Macau

Status: Not yet enrolling

Conditions: Cognitive Change; Ketoses, Metabolic; Overweight and Obesity

Treatments: Other: High-intensity interval exercise; Other: Moderate-intensity continuous exercise; Other: Placebo; Other: Ketone monoester supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06365957

BSERE24-APP001-FED

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 6 patient groups

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

Experimental group

Description:

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

Treatment:

Other: High-intensity interval exercise

Other: Ketone monoester supplementation

MICE-KT condition

Experimental group

Description:

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

Treatment:

Other: Moderate-intensity continuous exercise

Other: Ketone monoester supplementation

Nonexercise (NE)-KT condition

Experimental group

Description:

Non-exercise with ketone supplements.

Treatment:

Other: Ketone monoester supplementation

HIIE-Placebo (PLA) condition

Experimental group

Description:

HIIE with taste-matched placebo

Treatment:

Other: Placebo

Other: High-intensity interval exercise

MICE-PLA condition

Experimental group

Description:

MICE with taste-matched placebo

Treatment:

Other: Placebo

Other: Moderate-intensity continuous exercise

NE-PLA condition

Experimental group

Description:

Non-exercise with taste-matched placebo

Treatment:

Other: Placebo