Ketone Ester and Acute Salt (KEAS) in Young Adults
Most Americans consume excess dietary salt based on the recommendations set by the American Heart Association and Dietary Guidelines for Americans. High dietary salt impairs the ability of systemic blood vessels and the kidneys to control blood pressure, which contributes to excess salt consumption being associated with increased risk for chronic kidney disease and cardiovascular disease, the leading cause of death in America. There is a critical need for strategies to counteract the effects of high dietary salt as consumption is likely not going to decrease. One promising option is ketones, metabolites that are produced in the liver during prolonged exercise and very low-calorie diets. While exercise and low-calorie diets are beneficial, not many people engage in these activities. However, limited evidence indicates that ketone supplements improve cardiovascular health in humans. Additionally published rodent data indicates that ketone supplements prevent high salt-induced increases in blood pressure, blood vessel dysfunction, and kidney injury. Our human pilot data also indicates that high dietary salt reduces intrinsic ketone production, but it is unclear whether ketone supplementation confers humans protection against high salt similar to rodents. Therefore, the investigators seek to conduct a short-term high dietary salt study to determine whether ketone supplementation prevents high dietary salt from eliciting increased blood pressure, blood vessel dysfunction, and kidney injury/impaired blood flow. The investigators will also measure inflammatory markers in blood samples and isolate immune cells that control inflammation. Lastly, the investigators will also measure blood ketone concentration and other circulating metabolites that may be altered by high salt, which could allow us to determine novel therapeutic targets to combat high salt.
Conditions:
🦠 Salt; Excess
🦠 Hypertension
🗓️ Study Start (Actual)
24 March 2023
🗓️ Primary Completion (Estimated)
30 September 2025
✅ Study Completion (Estimated)
30 September 2026
👥 Enrollment (Estimated)
35
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Auburn, Alabama, United States
Description
Inclusion Criteria:
- * Between the ages of 18-39
- * Resting blood pressure no higher than 150/90
- * BMI below 35 kg/m2 (or otherwise healthy)
- * Free of any metabolic disease (diabetes or renal), pulmonary disorders (COPD or cystic fibrosis), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular), no autoimmune diseases, and no history of cancer
- * Do not have any precluding medical conditions (i.e. hemophilia) or medication (Pradaxa, Eliquis, etc.) that prevent participants from giving blood
- * Participants must be able to cycle on an exercise bike for up to one hour at a time.
Exclusion Criteria:
- * High blood pressure - greater the 150/90 mmHg
- * Low blood pressure - less than 90/50 mmHg
- * History of cardiovascular disease
- * History of cancer
- * History of diabetes
- * History of kidney disease
- * Obesity (BMI \> 30 kg/m2)
- * Smoking or tobacco use
- * Current pregnancy
- * Nursing mothers
- * Communication barriers
Ages Eligible for Study:
18 Years to 39 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Yes
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
31 August 2022
- First Submitted that Met QC Criteria
15 September 2022
- First Posted
19 September 2022
Study Record Updates
- Last Update Submitted that Met QC Criteria
30 May 2023
- Last Update Posted
31 May 2023
- Last Verified
May 2023