Clinical trial NCT04275453: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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:

1. 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.

Primary outcomes:
measure: Comparing the myocardial glucose suppression in Ketogenetic diet vs. external Ketone supplement by looking at the FDG uptake using PET/CT
timeFrame: 3 years
Secondary outcomes:
measure: The optimal duration of ketosis to produce myocardial suppression by looking at the FDG uptake using PET/CT by comparing the data out of 1 day keto diet Arm versus 3 days Keto diet Arm
timeFrame: 3 years
measure: Understanding the relationship between serum β-hydroxybutyrate (BHB) levels and myocardial glucose by looking at the FDG uptake using PET/CT by comparing the data out of keto diet Arm versus Ketone supplement Arm.
timeFrame: 3 years
measure: comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement
timeFrame: 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: