Recruiting

Ketone Ester

Sponsor:

Christopher Crabtree

Code:

NCT07711990

Conditions

Brain Health

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Accepted

Interventions

Ketone Ester Drink

Placebo

Study Details

Brief summary:

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.

Conditions

Brain Health

Study ID

NCT07711990

Start date

Jun 15, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Ketone Supplement drink

Drink contains 25 g of C8 Diester , 50g consumed total per day using split dose

placebo comparator: Placebo Drink

Drink contains no ketones, kcal and volume matched

Interventions

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

The placebo drink will be calorie and volume matched to the KE and be formulated with standard dietary ingredients.

Primary outcome measure

  • Cerebral Blood Flow [ Time Frame: Acute response following 2-day lead in ]
  • Brain Glutamate Concentration [ Time Frame: Acute response following 2-day lead in ]
  • Brain GABA Concentration [ Time Frame: Acute response following 2-day lead in ]
  • Brain Lactate Concentration [ Time Frame: Acute response following 2-day lead in ]
  • Brain Choline Concentration [ Time Frame: Acute response following 2-day lead in ]
  • Brain N-Acetylaspartate (NAA) Concentration [ Time Frame: Acute response following 2-day lead in ]
  • Brain Glucose Concentration [ Time Frame: Acute response following 2-day lead in ]
  • Brain Beta-Hydroxybutyrate (BHB) Concentration [ Time Frame: Acute response following 2-day lead in ]
  • Functional Brain Connectivity [ Time Frame: Acute response following 2-day lead in ]
  • Brain Acetoacetate Concentration [ Time Frame: Acute response following 2-day lead in ]
  • Brain Glutamine Concentration [ Time Frame: Acute response following 2-day lead in ]

Central Contacts and Locations

Central contacts

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

More Information

Sponsor

Christopher Crabtree

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • ketone supplement
  • brain MRI
  • brain MRS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christopher Crabtree on 2026-07-17.