The Brain Ketone Body Challenge Imaging Study

Not Applicable

Withdrawn

• Conditions: Alzheimer Disease
• Interventions: Dietary Supplement: Challenge A - low calorie Ensure®; Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE); Procedure: PET Scan; Behavioral: Cognitive Testing - FCSRT; Behavioral: Story Recall; Behavioral: BVRT; Behavioral: CogState One Card Learning

• Registration Number: NCT03204604
• Lead Sponsor: Wake Forest University Health Sciences

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 Timeline

• Study Start: 2016-08-08
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-07-02
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Challenge B	PET Scan	Challenge B includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with an Ensure® shake containing ketone esters. Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)
Challenge A	Challenge A - low calorie Ensure®	Challenge A includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with low calorie Ensure® shake containing no ketone esters. Dietary Supplement: Challenge A - low calorie Ensure®
Challenge A	Story Recall	Challenge A includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with low calorie Ensure® shake containing no ketone esters. Dietary Supplement: Challenge A - low calorie Ensure®
Challenge B	Cognitive Testing - FCSRT	Challenge B includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with an Ensure® shake containing ketone esters. Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)
Challenge A	PET Scan	Challenge A includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with low calorie Ensure® shake containing no ketone esters. Dietary Supplement: Challenge A - low calorie Ensure®
Challenge A	CogState One Card Learning	Challenge A includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with low calorie Ensure® shake containing no ketone esters. Dietary Supplement: Challenge A - low calorie Ensure®
Challenge A	Cognitive Testing - FCSRT	Challenge A includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with low calorie Ensure® shake containing no ketone esters. Dietary Supplement: Challenge A - low calorie Ensure®
Challenge B	Story Recall	Challenge B includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with an Ensure® shake containing ketone esters. Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)
Challenge B	BVRT	Challenge B includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with an Ensure® shake containing ketone esters. Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)
Challenge B	CogState One Card Learning	Challenge B includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with an Ensure® shake containing ketone esters. Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)
Challenge A	BVRT	Challenge A includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with low calorie Ensure® shake containing no ketone esters. Dietary Supplement: Challenge A - low calorie Ensure®
Challenge B	Challenge B - Ensure® plus ketone esters (KE)	Challenge B includes Cognitive testing - (FCSRT, Story Recall, BVRT, CogState One Card Learning), and PET scan with an Ensure® shake containing ketone esters. Dietary Supplement: Challenge B - Ensure® plus ketone esters (KE)

Primary Outcome Measures

Name	Time	Method
Primary Outcome - Brain Ketone Utilization	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 Outcome Measures

Name	Time	Method
Secondary Outcome - Memory Composite Score	2 weeks	How brain metabolism relates to the developement of memory problems. To look at memory score changes with ketone esters supplementation.

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States