RecruitingNot ApplicableNCT05545501

Ketone Ester and Salt (KEAS) in Young Adults

Ketone Supplementation as a Strategy to Reduce the Negative Health Effects of High Dietary Salt in Young Adults


Sponsor

Indiana University

Enrollment

35 participants

Start Date

Mar 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 19 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drink that combines ketone esters and ketone salts — substances that give the body an alternative energy source — in healthy young adults. The goal is to understand how these supplements affect exercise performance and metabolism. **You may be eligible if...** - You are between the ages of 19 and 39 - Your blood pressure is no higher than 150/90 - Your BMI is below 35 kg/m² - You are free from diabetes, kidney disease, serious lung conditions, and heart disease - You are able to exercise without medical restrictions **You may NOT be eligible if...** - Your blood pressure is greater than 150/90 - Your BMI is 30 or higher (obese) - You have diabetes, kidney disease, COPD, severe asthma, cystic fibrosis, or cardiovascular disease - You have joint or muscle problems that prevent exercise - You take blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTNo Salt, No β-OHB

Participants will consume the following for ten days. Enteric capsules will be filled with a dextrose placebo. The placebo supplement will be a β-OHB-free, taste and viscosity-matched, beverage produced by KetoneAid.

DIETARY_SUPPLEMENTHigh Salt, No β-OHB

Participants will consume the following for ten days. Enteric capsules will be filled with Morton's table salt. Sodium consumption will be normalized to caloric intake (2 mg Sodium/Calorie). The placebo supplement will be a β-OHB-free, taste and viscosity-matched, beverage produced by KetoneAid.

DIETARY_SUPPLEMENTHigh Salt, High β-OHB

Participants will consume the following for ten days. Enteric capsules will be filled with Morton's table salt. Sodium consumption will be normalized to caloric intake (2 mg Sodium/Calorie). Ketone beverage will be the β-OHB supplement produced by KetoneAid. Participants will consume 24 mL (12 grams β-OHB) of the ketone beverage three times a day (total 36 grams β-OHB).


Locations(2)

Auburn University

Auburn, Alabama, United States

Indiana University, School of Public Health

Bloomington, Indiana, United States

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NCT05545501


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