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

NCT ID: NCT04275453

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-05
• Study Completion Date: 2023-01-05

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FDG

Intervention Type: DRUG

FDG is a FDA approved radiotracer which each subject will have 3 positron emission tomography/computed tomography (PET/CT) scan performed.

Ketogenetic Diet

Intervention Type: OTHER

Subjects needs to be on Ketogenetic diet

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.

Group Type: EXPERIMENTAL

FDG

Intervention Type: DRUG

FDG is a FDA approved radiotracer which each subject will have 3 positron emission tomography/computed tomography (PET/CT) scan performed.

Ketogenetic Diet

Intervention Type: OTHER

Subjects needs to be on Ketogenetic diet

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.

Group Type: EXPERIMENTAL

FDG

Intervention Type: DRUG

FDG is a FDA approved radiotracer which each subject will have 3 positron emission tomography/computed tomography (PET/CT) scan performed.

Ketone Drink

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

FDG

FDG is a FDA approved radiotracer which each subject will have 3 positron emission tomography/computed tomography (PET/CT) scan performed.

Intervention Type: DRUG

Ketone Drink

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: DIETARY_SUPPLEMENT

Ketogenetic Diet

Subjects needs to be on Ketogenetic diet

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Zeinab Helili

Role: primary

zeinab.helili@uphs.upenn.edu

215-746-3230

Erin Schubert

Role: backup

Erin.Schubert@uphs.upenn.edu

215-573-6569

Other Identifiers

834253

Identifier Type: -

Identifier Source: org_study_id