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

16 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

24

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Ketone Supplement drink
Drink contains 25 g of C8 Diester , 50g consumed total per day using split dose
Voedingssupplement: 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.
Placebo-vergelijker: Placebo Drink
Drink contains no ketones, kcal and volume matched
Voedingssupplement: Placebo
The placebo drink will be calorie and volume matched to the KE and be formulated with standard dietary ingredients.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cerebral Blood Flow
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Blood Ketone Concentration
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Christopher Crabtree

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 juni 2026

Primaire voltooiing (Geschat)

1 december 2029

Studie voltooiing (Geschat)

1 december 2029

Studieregistratiedata

Eerst ingediend

13 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juli 2026

Eerst geplaatst (Werkelijk)

17 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

16 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • STUDY20251460

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Decision on data sharing not yet finalized.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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