RecruitingNot ApplicableNCT06868719

Ketone Ester And Salt (KEAS) in Older Adults

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


Sponsor

Indiana University

Enrollment

30 participants

Start Date

Mar 6, 2025

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 blood pressure control by affecting systemic blood vessels and the kidneys. These changes contribute to excess salt consumption being associated with increased risk for chronic kidney disease and cardiovascular disease, the leading cause of death in America. Salt is particularly deleterious in older adults who are more likely to exhibit salt-sensitive hypertension. However, salt consumption remains high in the United States. Thus, 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. 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 facilitate novel therapeutic targets to combat high salt.


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests different forms of ketone supplements (ketone esters and salts) to see how they affect energy, metabolism, and physical performance in healthy older adults. **You may be eligible if...** - You are between 60 and 85 years old - Your resting blood pressure is no higher than 150/90 - Your BMI is below 35 kg/m2 - You are free of metabolic diseases (no diabetes or kidney disease), pulmonary disorders, and cardiovascular disease **You may NOT be eligible if...** - You have diabetes, kidney disease, COPD, severe asthma, or cystic fibrosis - You have cardiovascular disease (heart disease, stroke history, or peripheral vascular disease) - You have a medical condition that prevents safe exercise or study participation - You are currently taking medications that may interact with the study supplements 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(1)

School of Public Health

Bloomington, Indiana, United States

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NCT06868719


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