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

NCT04275453 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 834253
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (3)

• 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

  3 years

• 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.

  3 years

• comparing the transthoracic echocardiogram changes before and after the Ketone supplement drink to assess the effect of Ketone supplement

  3 years

Study Arms (3)

Ketogenic diet - 24 hours

EXPERIMENTAL

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.

Drug: FDG; Other: Ketogenetic Diet

Ketogenic diet - 72 hours

EXPERIMENTAL

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.

Drug: FDG; Other: Ketogenetic Diet

Exogenous ketone ester

EXPERIMENTAL

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.

Drug: FDG; Dietary Supplement: Ketone Drink

Interventions

FDG DRUG

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

Exogenous ketone ester; Ketogenic diet - 24 hours; Ketogenic diet - 72 hours

Ketone Drink 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

Exogenous ketone ester

Ketogenetic Diet OTHER

Subjects needs to be on Ketogenetic diet

Ketogenic diet - 24 hours; Ketogenic diet - 72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: February 19, 2020
• Study Start: January 5, 2020
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2023
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)