NCT06368297

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

The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults: A Neurophysiological and Resting Functional Magnetic Resonance Study (rfMRI)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Macau · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Overweight and Obesity
• Cognitive Change
• Psychophysiologic Reaction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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, β-hydroxybutyrate \[β-HB\], and acetone).
DIETARY_SUPPLEMENT	Ketogenic diet	The ketogenic diet typically reduces total carbohydrate intake to less than 50 grams a day-less than the amount found in a medium plain bagel-and can be as low as 20 grams a day. Generally, popular ketogenic resources suggest an average of 70-80% fat from total daily calories, 5-10% carbohydrate, and 10-20% protein.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2024-04-16
• Last updated: 2024-04-16