Clinical trial NCT03204604: The Brain Ketone Body Challenge Imaging Study
Official title: The Brain Ketone Body Challenge Imaging Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Memory
Dietary Treatment
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Challenge A - low calorie Ensure® shake Challenge B - low calorie Ensure® shake with ketone esters
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary Outcome - Brain Ketone Utilization
timeFrame: 2 weeks
Secondary outcomes:
measure: Secondary Outcome - Memory Composite Score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Timothy R Hughes, PhD
role: PRINCIPAL_INVESTIGATOR
References: