Effects of Acute Ketone Supplementation on the Brain

ConditionBrain Health

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45-65

SponsorChristopher Crabtree

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

Ketone Ester Drink
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
Dietary supplement
The placebo drink will be calorie and volume matched to the KE and be formulated with standard dietary ingredients.

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Ketone Supplement drinkActive comparator 1 intervention

Group B: Placebo DrinkPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Cerebral Blood Flow

To detect a clinically meaningful difference in cerebral blood flow (CBF) between ketone ester and placebo conditions in healthy adults

Time frame