Ketone Ester and Salt (KEAS) in Young Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-39
SponsorIndiana University

About this trial

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.

Eligibility criteria

Qualifiers

Between the ages of 19-39

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, severe asthma, & cystic fibrosis), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular)

Disqualifiers

High blood pressure - greater than 150/90 mmHg

Obesity (BMI > 30 kg/m2)

History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, & cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).

Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis)

Trial design

Treatments tested in this trial

  • No Salt, No β-OHB
  • High Salt, No β-OHB
  • High Salt, High β-OHB

Treatment groups

35 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

University of Utah

Collaborator

University of Missouri-Columbia

Collaborator