Back to resultsComparison 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
Primary Purpose
Healthy
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FDG
Ketone Drink
Ketogenetic Diet
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Adult patients, at least 18 years of age
- No history of cardiovascular disease, including hypertension, hyperlipidemia, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report
- No history of diabetes mellitus, chronic liver or kidney disease per medical record review and/or self-report.
- 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.
- Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
- 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.
Sites / Locations
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ketogenic diet - 24 hours
Ketogenic diet - 72 hours
Exogenous ketone ester
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Comparing the myocardial glucose suppression in Ketogenetic diet vs. external Ketone supplement by looking at the FDG uptake using PET/CT
Comparing the myocardial glucose suppression in Ketogenetic diet vs. external Ketone supplement by looking at the FDG uptake using PET/CT. Images will be qualitative and semi-quantitatively assessed. The entire right and left ventricular walls will be contoured in a dedicated nuclear medicine workstation (MIM Software) to create volume of interest s(VOI) and derive the maximum and mean standardized uptake value (SUV) and total glycolytic activity (TGA), all measures of glucose utilization. Blood pool activity within the left ventricular cavity will be used as reference. Complete myocardial suppression will be defined as FDG activity (by any measure) in the left ventricular wall lower than blood pool activity in the ventricular cavity.
Secondary Outcome Measures
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
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.
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.
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 by measuring serum levels of BHB, free fatty acid, acylcarnitine, glucose, and insulin at each FDG PET/CT visit. Approximately 15 mLs of blood will be drawn and used to measure B-Hydroxybutyrate (BHB), acylcarnitines, insulin, glucose and free fatty acid and other targeted metabolomics
comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement
comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement. Transthoracic Echocardiogram: Ultrasound will be used to create an image of the internal parts of the heart. This test is being done to assess any changes in cardiac function with the ketone drink. We will perform echocardiography before and approximately 30 minutes after the drink.
Full Information
NCT ID
NCT04275453
First Posted
January 6, 2020
Last Updated
July 15, 2020
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04275453
Brief 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
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2020 (Actual)
Primary Completion Date
January 5, 2022 (Anticipated)
Study Completion Date
January 5, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet - 24 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Ketogenic diet - 72 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
Exogenous ketone ester
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FDG
Intervention Description
FDG is a FDA approved radiotracer which each subject will have 3 positron emission tomography/computed tomography (PET/CT) scan performed.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone Drink
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Ketogenetic Diet
Intervention Description
Subjects needs to be on Ketogenetic diet
Primary Outcome Measure Information:
Title
Comparing the myocardial glucose suppression in Ketogenetic diet vs. external Ketone supplement by looking at the FDG uptake using PET/CT
Description
Comparing the myocardial glucose suppression in Ketogenetic diet vs. external Ketone supplement by looking at the FDG uptake using PET/CT. Images will be qualitative and semi-quantitatively assessed. The entire right and left ventricular walls will be contoured in a dedicated nuclear medicine workstation (MIM Software) to create volume of interest s(VOI) and derive the maximum and mean standardized uptake value (SUV) and total glycolytic activity (TGA), all measures of glucose utilization. Blood pool activity within the left ventricular cavity will be used as reference. Complete myocardial suppression will be defined as FDG activity (by any measure) in the left ventricular wall lower than blood pool activity in the ventricular cavity.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
3 years
Title
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.
Description
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 by measuring serum levels of BHB, free fatty acid, acylcarnitine, glucose, and insulin at each FDG PET/CT visit. Approximately 15 mLs of blood will be drawn and used to measure B-Hydroxybutyrate (BHB), acylcarnitines, insulin, glucose and free fatty acid and other targeted metabolomics
Time Frame
3 years
Title
comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement
Description
comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement. Transthoracic Echocardiogram: Ultrasound will be used to create an image of the internal parts of the heart. This test is being done to assess any changes in cardiac function with the ketone drink. We will perform echocardiography before and approximately 30 minutes after the drink.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients, at least 18 years of age
No history of cardiovascular disease, including hypertension, hyperlipidemia, coronary artery disease, cardiac surgery, arrhythmias per medical record review and/or self-report
No history of diabetes mellitus, chronic liver or kidney disease per medical record review and/or self-report.
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.
Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
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.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeinab Helili
Phone
215-746-3230
Email
zeinab.helili@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Erin Schubert
Phone
215-573-6569
Email
Erin.Schubert@uphs.upenn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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