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Ketone Ester And Salt (KEAS) in Older Adults

Study acronym: KEAS-O
StatusRecruiting
PhaseNot applicable
Started2025-03-06
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 31, 2027 → Dec 31, 2027
See other at-risk trials from Indiana University

Amendment history

2026-08-18
notable
Study Status v5
Primary completion pushed: 2027-08-31 → 2027-12-31
2026-06-16
minor
Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v4
Primary completion date2027-12-31→2027-08-31
Enrollment target30→35
Secondary endpoints1 to 5 entries
Post-exercise resting blood pressure Post-exercise ambulatory blood pressure Kidney blood velocity Passive Leg movement
Primary endpoints1 to 2 entries
Resting blood pressure
2025-10-28
minor
Study Identification, Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility v3
Eligibility criteria+224 characters
Inclusion Criteria: Between the ages of 5060-85 Resting blood pressure no higher than 150/90 BMI below 3 [...] r 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 exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners) Participants must be able to cycle on an exercise bike for up to one hour at a time. Exclusion Criteria: High blood pre [...] [...]
Study description+1,402 characters
[...] lood samples using parallel in vitro and applied approaches. Participants will report to the laboratory for four visits. At the first visit, consent for study participation will be obtained and participants will be screened for eligibility. Participants will then be randomly assigned to a crossover schedule for exposure to salt and ketone supplementation. Su [...]
2025-08-14
minor
Study Status, Outcome Measures, Eligibility v2
Eligibility criteria+11 characters
[...] bolic disease (diabetes or renal), pulmonary disorders (COPD, severe asthma, or cystic fibrosis), cardiovascular disease (peripheral vas [...] sion Criteria: High blood pressure - greater the150/90 mmHg Low blood pressure - less than 90/50 mmHg History of cardiovascular disease History of cancer History [...] diabetes History of kidney disease Obesity (BMI > 30 kg/m2) SmokingCurrent smoking, using smokeless tobacco, or tobaccovaping use(within past 12 months) Current pregnancy Nursing mothers
Secondary endpoints5 to 1 entries
InflammatoryFlow cellmediated responsesdilation to Conditions Inflammatory cytokine responses to Conditions Changes in circulating reactive oxygen species Changes in blood biomarkers of nitric oxide bioavailability Changes in blood biomarkers of plasma metabolome(FMD)
Primary endpoints6 to 1 entries
Flow mediated dilation (FMD) Kidney blood velocity Passive Leg movement Pulse wave analysis Pulse wave velocity
2025-03-17
minor
Study Identification, Study Status, Sponsor/Collaborators v1
Primary completion date2027-05-01→2027-12-31
Collaborators2 to 3 entries
National Institute on Aging (NIA)
2025-03-10
minor
Original filing
1,783 trials monitored
See 75 trials at risk
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.
Trial Details
NCT Number NCT06868719
Lead Sponsor Indiana University
Collaborators: University of Utah, University of Missouri-Columbia, National Institute on Aging (NIA)
Conditions Salt; Excess, Hypertension, Aging, Inflammation, Blood Pressure
Enrollment 35 participants
Start Date 2025-03-06
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-19