The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults

University of Macau

Status: Not yet enrolling

Conditions: Cognitive Change; Overweight and Obesity; Psychophysiologic Reaction

Treatments: Dietary Supplement: Ketogenic diet; Dietary Supplement: Ketone Monoester Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06368297

BSERE22-APP007-FED

Details and patient eligibility

About

This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses.

Full description

The study initially makes a bold attempt to explore whether the ketone supplementation would induce improvements in the overweight/ obese population's brain health via altering motor cortex plasticity, brain function and structure, and metabolic and neuroendocrine pathways. The study's aims include:

• assessing changes in brain plasticity associated with excessive body weight and/or obesity.
• evaluating the potential of ketone monoester supplementation in enhancing brain plasticity.
• evaluating the potential of ketone monoester supplementation in correcting impaired brain plasticity due to excessive body weight.
• evaluating the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity.
• investigating structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation.
• assessing the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) > 25 and < 35 kg/m2 (overweight/obese group) or BMI > 18.5 and < 25 kg/m2 (healthy weight group);
• Right-handed.

Exclusion criteria

• Presenting any established counter indication for transcranial magnetic stimulation;
• Currently taking any medication affecting the central or the peripheral nervous system;
• Suffering from any psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus;
• Undertaking surgery in the past six months;
• Engaged in resistance training.
• Pregnancy;
• Breastfeeding;
• Being amenorrhea.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Acute effect of ketone monoester supplementation

Experimental group

Description:

To investigate the acute effect of ketone monoester ingestion on brain cortical plasticity using high-frequency rTMS.

Treatment:

Dietary Supplement: Ketone Monoester Supplementation

Effects of a 2-week ketogenic diet or ketone monoester supplementation

Experimental group

Description:

To evaluate the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity. To investigate structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation. To assess the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation.

Treatment:

Dietary Supplement: Ketone Monoester Supplementation

Dietary Supplement: Ketogenic diet