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

2026年7月16日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

24

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Ketone Supplement drink
Drink contains 25 g of C8 Diester , 50g consumed total per day using split dose
ダイエットサプリメント：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.
プラセボコンパレーター：Placebo Drink
Drink contains no ketones, kcal and volume matched
ダイエットサプリメント：Placebo
The placebo drink will be calorie and volume matched to the KE and be formulated with standard dietary ingredients.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Cerebral Blood Flow
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Blood Ketone Concentration
時間枠：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
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Christopher Crabtree

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月15日

一次修了 (推定)

2029年12月1日

研究の完了 (推定)

2029年12月1日

試験登録日

最初に提出

2026年7月13日

QC基準を満たした最初の提出物

2026年7月16日

最初の投稿 (実際)

2026年7月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月17日

QC基準を満たした最後の更新が送信されました

2026年7月16日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • STUDY20251460

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

Decision on data sharing not yet finalized.

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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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