The Brain Ketone Body Challenge Imaging Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Primary Outcome - Brain Ketone Utilization
Study Overview
Brief Summary
The Brain Ketone Body Challenge Imaging Study will measure how the brain uses different fuels. To do this, radioactive compounds will be used during Positron Emission Tomography (PET) imaging.
These compounds, called [11C]Acetoacetate (AcAc) and [18F] Fludeoxyglucose (FDG), are similar to the sugars and fats the brain already uses for fuel. These compounds safely allow researchers to see how the brain uses sugars and fats during PET scans.
Detailed Description
After consuming a chilled 4 ounce shake which contains various dietary fats, cognitive testing and dual-tracer Positron Emission Tomography scan will be completed. At Visit 1, each participant will be randomized to Challenge A (low calorie Ensure®) or Challenge B (Ensure® plus ketone esters). At Visit 2, each participant will undergo the remaining challenge (A or B) prior to the second imaging session. Each visit is designed to be identical to the other and only vary the dose of ketone esters. Randomization to either Challenge at Visit 1 will ensure that test/re-test learning effects are equally distributed between the challenge groups. This study consists of two visits that will take place over a two week period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Visits are listed at Challenge A or Challenge B. This serves as a double blind crossover intervention for participants and clinic staff.
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Mild Cognitive Impairment (MCI)
- •Stable medical condition
- •Stable on medications for past 4 weeks
- •Women must be post-menopausal
Exclusion Criteria
- •Diagnosis of neurodegenerative illness (except for MCI)
- •History of a clinically significant stroke
- •Current evidence or history in past year of focal brain lesion, head injury with loss of consciousness or meeting any Diagnostic and Statistical Manual 4 (DSM-IV) criteria for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
- •Diabetes that requires current use of diabetes medications
- •Current use of cholesterol/lipid lowering medications
- •History of epilepsy or seizure within past year
- •Contraindications for imaging (e.g. claustrophobia or high prior radiation exposure)
Outcomes
Primary Outcomes
Primary Outcome - Brain Ketone Utilization
Time Frame: 2 weeks
The relative global uptake of \[11C\]AcAc during Challenge B compared to Challenge A. within each individual. How the brain uses sugars and fats for fuel and who is more likely to respond to dietary treatments.
Secondary Outcomes
- Secondary Outcome - Memory Composite Score(2 weeks)