Comparing dietary carbohydrate restriction and ketone supplementation for heart imaging preparation
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
This study tests whether a low-carb diet or ketone supplements help healthy adults prepare better for heart scans by reducing sugar uptake in the heart.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04275453 on ClinicalTrials.gov |
What this trial studies
This study investigates different preparation methods for FDG PET/CT scans, which are used to evaluate heart inflammation. Participants will try up to three different methods, including a ketogenic diet and exogenous ketone supplementation, to determine which is most effective in reducing sugar uptake in the heart. The goal is to improve the accuracy of heart imaging by identifying the best preparation approach. The study involves healthy adults with no history of cardiovascular disease or diabetes.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older with no history of cardiovascular disease or diabetes.
Not a fit: Patients with existing cardiovascular conditions, diabetes, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of heart imaging tests, leading to better diagnosis and management of heart conditions.
How similar studies have performed: While similar approaches have been explored, this specific comparison of dietary methods and ketone supplementation is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.