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

16. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

24

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Ketone Supplement drink
Drink contains 25 g of C8 Diester , 50g consumed total per day using split dose
Nahrungsergänzungsmittel: 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-Komparator: Placebo Drink
Drink contains no ketones, kcal and volume matched
Nahrungsergänzungsmittel: Placebo
The placebo drink will be calorie and volume matched to the KE and be formulated with standard dietary ingredients.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cerebral Blood Flow
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Blood Ketone Concentration
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Christopher Crabtree

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Juni 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2029

Studienabschluss (Geschätzt)

1. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

13. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juli 2026

Zuerst gepostet (Tatsächlich)

17. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • STUDY20251460

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Beschreibung des IPD-Plans

Decision on data sharing not yet finalized.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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