Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
Purpose
The purpose of this study is to test different methods of preparation that can be used prior to a test called an FDG PET/CT scan. FDG PET/CT scans are routinely done for evaluation of heart inflammation. Standard preparation for the scan includes a ketogenic (high fat and low carbohydrate) diet for 24 hours and overnight fasting to help suppress the amount of sugar taken up in the heart muscle. However, Investigator still do not know if this preparation is the most effective method. So the Investigator, want to investigate alternative methods for decreasing the amount of sugar uptake seen in the heart during FDG PET/CT scan, thus, investigator will have participants try up to 3 different methods of preparation prior to the FDG PET/CT scans to see which type of preparation works the best.
Condition
- Healthy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Adult patients, at least 18 years of age 2. No history of cardiovascular disease, including hypertension, hyperlipidemia, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report 3. No history of diabetes mellitus, chronic liver or kidney disease per medical record review and/or self-report. 4. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion Criteria
- Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test before the first study visit. 2. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician. 3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ketogenic diet - 24 hours |
Subjects will undergo FDG PET/CT after 1 day of dietary modification (ketogenic diet for at least 3 meals) and 12 hours of fasting prior to FDG injection. |
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Experimental Ketogenic diet - 72 hours |
Subjects will then undergo FDG PET/CT after 3 day of dietary modification (ketogenic diet for at least 9 meals) and 12 hours of fasting prior to FDG injection. |
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Experimental Exogenous ketone ester |
Subjects will undergo FDG PET/CT after 1 dose of ketone drink administration after 12 hours of fasting prior to FDG injection. The dosing of ketone drink administration (approximately 65 mL) will be weight based (714 mg/kg), which is crucial to replicating ketone levels between participants. The KE drink will be administered approximately 45 minutes prior to FDG injection as concentrations of ~3 mmol/L are reached within 60 minutes . By way of comparison, website marketing of the commercial drink recommends ingestion 30 minutes prior to athletic performance. We will also perform echocardiography immediately before and 30 minutes after the drink. |
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Recruiting Locations
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
More Details
- NCT ID
- NCT04275453
- Status
- Recruiting
- Sponsor
- University of Pennsylvania