What this study is
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.
What's being tested
- Ketone Ester Drink
Intervention · DIETARY SUPPLEMENT
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
Intervention · DIETARY SUPPLEMENT
The placebo drink will be calorie and volume matched to the KE and be formulated with standard dietary ingredients.
Study details
- Official title
- Effects of Acute Ketone Supplementation on the Brain [KETO-BRAIN]
- Sponsor
- Christopher Crabtree
- Conditions
- Brain Health
- Enrolling
- 24 people
- Starts
- 2026-06-15
- Est. completion
- 2029-12
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Age ≥45 years and ≤65 years
- 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.
- BMI between 18.5 and 30 kg/m2
You can't join if
- Non-English Speaking
- Currently taking a ketone ester supplement, ketone salt supplement, or on a ketogenic diet
- Pregnancy, a urine pregnancy test will be given to all women before scanning to confirm nonpregnant status
- Currently breastfeeding
- Allergies to components in the test products, including milk protein, and not lactose intolerant
- History of high blood pressure
- History of alcoholism (previous 2 years)
- History of illicit drug use
- History of head trauma involving loss of consciousness or skull fracture
- Diagnosed neurological disease
- 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)
- Current smoker
- Currently consuming a habitual ketogenic diet, or was consuming a habitual ketogenic diet in the past three months
- Any condition or material in the body that is a contraindication for MRI procedures
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openThe Ohio State University
Columbus, Ohio, United States
- Christopher Crabtree, Ph.D. · Contact614-688-5623Chrisstopher.Crabtree@osumc.edu
Recruiting
Study team
Sponsor
Christopher Crabtree
Study ID STUDY20251460
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.