The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults
NCT ID: NCT06368297
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-04-30
2024-08-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Acute effect of ketone monoester supplementation
To investigate the acute effect of ketone monoester ingestion on brain cortical plasticity using high-frequency rTMS.
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).
Effects of a 2-week ketogenic diet or ketone monoester supplementation
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.
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).
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
* Right-handed.
Exclusion Criteria
* 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.
20 Years
50 Years
ALL
Yes
Sponsors
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University of Macau
OTHER
Responsible Party
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Principal Investigators
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Zhaowei Kong, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Macau
Central Contacts
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References
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Falkenhain K, Daraei A, Forbes SC, Little JP. Effects of Exogenous Ketone Supplementation on Blood Glucose: A Systematic Review and Meta-analysis. Adv Nutr. 2022 Oct 2;13(5):1697-1714. doi: 10.1093/advances/nmac036.
Evans M, McClure TS, Koutnik AP, Egan B. Exogenous Ketone Supplements in Athletic Contexts: Past, Present, and Future. Sports Med. 2022 Dec;52(Suppl 1):25-67. doi: 10.1007/s40279-022-01756-2. Epub 2022 Oct 10.
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.
Walsh JJ, Neudorf H, Little JP. 14-Day Ketone Supplementation Lowers Glucose and Improves Vascular Function in Obesity: A Randomized Crossover Trial. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1738-e1754. doi: 10.1210/clinem/dgaa925.
Yu Q, Wong KK, Lei OK, Armada-da-Silva PAS, Wu Z, Nie J, Shi Q, Kong Z. Acute ketone monoester supplementation in young adults: modulating metabolic and neurocognitive functions across body weights. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-12. doi: 10.1139/apnm-2024-0229. Epub 2024 Oct 17.
Other Identifiers
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BSERE22-APP007-FED
Identifier Type: -
Identifier Source: org_study_id
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