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Recruiting NCT06868719

NCT06868719 Ketone Ester And Salt (KEAS) in Older Adults

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Clinical Trial Summary
NCT ID NCT06868719
Status Recruiting
Phase
Sponsor Indiana University
Condition Salt; Excess
Study Type INTERVENTIONAL
Enrollment 35 participants
Start Date 2025-03-06
Primary Completion 2027-12-31

Eligibility & Interventions

Sex All sexes
Min Age 50 Years
Max Age 85 Years
Study Type INTERVENTIONAL
Interventions
No Salt, No β-OHBHigh Salt, No β-OHBHigh Salt, High β-OHB

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 35 participants in total. It began in 2025-03-06 with a primary completion date of 2027-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

Inclusion Criteria: * Between the ages of 60-85 * 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, or cystic fibrosis), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular) * Do not have any precluding medical conditions that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners) Exclusion Criteria: * High blood pressure - greater than150/90 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) * Medical issues that prevent giving blood (e.g., blood thinners). * Current smoking, using smokeless tobacco, or vaping (within past 12 months) * Current pregnancy

Contact & Investigator

Central Contact

Austin T Robinson, PhD

✉ ausrobin@iu.edu

📞 5745141034

Frequently Asked Questions

Who can join the NCT06868719 clinical trial?

This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Salt; Excess. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06868719 currently recruiting?

Yes, NCT06868719 is actively recruiting participants. Contact the research team at ausrobin@iu.edu for enrollment information.

Where is the NCT06868719 trial being conducted?

This trial is being conducted at Bloomington, United States.

Who is sponsoring the NCT06868719 clinical trial?

NCT06868719 is sponsored by Indiana University. The trial plans to enroll 35 participants.

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