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Effects of Acute Ketone Supplementation on the Brain (KETO-BRAIN)

16. července 2026 aktualizováno: Christopher Crabtree

Effects of Acute Ketone Supplementation on the Brain [KETO-BRAIN]

The purpose of this study is to determine how a ketone ester supplement affects brain function, brain blood flow, and brain metabolism in healthy middle-aged and older adults. Ketones are naturally produced by the body during periods of fasting or carbohydrate restriction and serve as an alternative fuel source for the brain. Researchers are interested in whether increasing blood ketone levels through supplementation can alter brain activity and blood flow in ways that may support healthy brain function.

Participants will consume a ketone ester supplement and a placebo in separate study visits. Brain imaging, blood measurements, and cognitive testing will be used to evaluate the effects of each intervention. Findings from this study will help researchers better understand how ketones influence the healthy aging brain and may provide preliminary data for future studies in populations at risk for cognitive decline.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

Alzheimer's disease and other age-related neurodegenerative conditions are associated with changes in brain energy metabolism that can occur years before symptoms develop. One of the earliest findings in these conditions is reduced utilization of glucose by certain brain regions. Ketones, including beta-hydroxybutyrate, can serve as an alternative fuel source for the brain and may help support brain metabolism when glucose utilization is impaired. Experimental evidence also suggests ketones may influence cerebral blood flow, neurotransmitter balance, and functional brain connectivity.

Despite growing interest in ketone supplementation, the acute effects of ketone esters on multiple aspects of human brain function have not been comprehensively evaluated. This study will investigate whether acute ketone ester ingestion alters cerebral blood flow, brain neurochemistry, resting-state brain connectivity, and cognitive performance in healthy adults.

This is a randomized, double-blind, placebo-controlled crossover study. Participants will complete two intervention periods, receiving a ketone ester supplement during one period and a calorie-matched placebo during the other. The order of interventions will be randomized and separated by a washout period of 3 to 7 days. Participants will consume study beverages for two days prior to each testing session and will undergo detailed testing following an overnight fast.

At each testing visit, participants will provide fingerstick blood samples to measure ketone and glucose concentrations, complete standardized cognitive testing, and undergo advanced magnetic resonance imaging (MRI). Brain imaging will include arterial spin labeling (ASL) to evaluate cerebral blood flow, proton magnetic resonance spectroscopy (1H-MRS) to assess brain metabolite and neurotransmitter concentrations, and functional MRI (fMRI) to assess resting-state brain network connectivity. Cardiac MRI measures will also be collected to explore relationships between cardiovascular and cerebrovascular responses.

The primary goal is to determine whether acute ketone supplementation changes cerebral blood flow, brain metabolite concentrations, and functional brain connectivity compared with placebo. Secondary analyses will evaluate relationships between blood ketone concentrations, imaging measures, and cognitive performance. Results from this pilot study will provide important mechanistic information regarding how ketones affect the healthy aging brain and will support the development of future clinical trials in populations at risk for cognitive impairment.

The study lasts about two weeks. There are two main test days with 3-7 days in between. Each testing session will last up to 3.5 hours at most.

Typ studie

Intervenční

Zápis (Odhadovaný)

24

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion Criteria:

  1. Age ≥45 years and ≤65 years
  2. Able to comply with study requirements including presenting for each test session following an overnight fast and not following a ketogenic diet during the duration of the study.
  3. BMI between 18.5 and 30 kg/m2

Exclusion Criteria:

  1. Non-English Speaking
  2. Currently taking a ketone ester supplement, ketone salt supplement, or on a ketogenic diet
  3. Pregnancy, a urine pregnancy test will be given to all women before scanning to confirm nonpregnant status
  4. Currently breastfeeding
  5. Allergies to components in the test products, including milk protein, and not lactose intolerant
  6. History of high blood pressure
  7. History of alcoholism (previous 2 years)
  8. History of illicit drug use
  9. History of head trauma involving loss of consciousness or skull fracture
  10. Diagnosed neurological disease
  11. Taking psychiatric prescriptive medications (antipsychotics, antidepressants, or barbiturates) or over-the-counter (OTC) medications (other than those taken as nutritional supplements for non-therapeutic indications)
  12. Current smoker
  13. Currently consuming a habitual ketogenic diet, or was consuming a habitual ketogenic diet in the past three months
  14. Any condition or material in the body that is a contraindication for MRI procedures

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Ketone Supplement drink
Drink contains 25 g of C8 Diester , 50g consumed total per day using split dose
Doplněk stravy: Ketone Ester Drink

The ketone ester beverage contains 25 g of C8 Diester emulsified in a matrix of water, whey protein concentrate, modified gum acacia, natural and artificial flavors and cocoa powder. It contains 210 kcal, 0.5 g fat, 2 g carbohydrates, and 2 g protein. Dose consumed is 50 g, 2 times per day for 2 days.

The placebo (PL) will be calorie and volume matched to the KE and be formulated with standard dietary ingredients.
Komparátor placeba: Placebo Drink
Drink contains no ketones, kcal and volume matched
Doplněk stravy: Placebo
The placebo drink will be calorie and volume matched to the KE and be formulated with standard dietary ingredients.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Cerebral Blood Flow
Časové okno: Acute response following 2-day lead in
To detect a clinically meaningful difference in cerebral blood flow (CBF) between ketone ester and placebo conditions in healthy adults
Acute response following 2-day lead in
Brain Glutamate Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain glutamate concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in
Brain GABA Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain gamma-aminobutyric acid (GABA) concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in
Brain Lactate Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain lactate concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in
Brain Choline Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain choline concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in
Brain N-Acetylaspartate (NAA) Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain N-acetylaspartate (NAA) concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in
Brain Glucose Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain glucose concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in
Brain Beta-Hydroxybutyrate (BHB) Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain beta-hydroxybutyrate (BHB) concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in
Functional Brain Connectivity
Časové okno: Acute response following 2-day lead in
Change in resting-state brain network connectivity measured using blood oxygen level-dependent functional magnetic resonance imaging (BOLD-fMRI).
Acute response following 2-day lead in
Brain Acetoacetate Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain acetoacetate concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in
Brain Glutamine Concentration
Časové okno: Acute response following 2-day lead in
To detect a difference in brain glutamine concentration (mM) between ketone ester and placebo conditions in healthy adults, measured using proton magnetic resonance spectroscopy (1H-MRS).
Acute response following 2-day lead in

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Blood Ketone Concentration
Časové okno: Acute response following 2-day lead in
Blood beta-hydroxybutyrate concentrations measured by fingerstick testing.
Acute response following 2-day lead in
Blood Glucose Concentration
Časové okno: Acute response following 2-day lead in
Blood glucose concentrations measured by fingerstick testing.
Acute response following 2-day lead in
Cognitive Performance (RBANS Total Scale Score)
Časové okno: Acute response following 2-day lead in
Total Scale Score on the RBANS, comparing ketone ester and placebo conditions in healthy adults.
Acute response following 2-day lead in

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Christopher Crabtree

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. června 2026

Primární dokončení (Odhadovaný)

1. prosince 2029

Dokončení studie (Odhadovaný)

1. prosince 2029

Termíny zápisu do studia

První předloženo

13. července 2026

První předloženo, které splnilo kritéria kontroly kvality

16. července 2026

První zveřejněno (Aktuální)

17. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • STUDY20251460

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

Decision on data sharing not yet finalized.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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