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NCT05545501 · ClinicalTrials.gov registry record · NA
Ketone Ester and Salt (KEAS) in Young Adults
A NA study of Hypertension and Salt; Excess, sponsored by Indiana University.
- Recruiting
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 2
- Study locations
NCT05545501 is a NA study of Hypertension and Salt; Excess that is actively recruiting participants, run by Indiana University. The registered enrollment target is 35 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05545501, a NA study of Hypertension and Salt; Excess, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT No Salt, No β-OHB
- DIETARY_SUPPLEMENT High Salt, No β-OHB
- DIETARY_SUPPLEMENT High Salt, High β-OHB
Study Locations (2)
Alabama
- Auburn University - Auburn
Indiana
- Indiana University, School of Public Health - Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-03-24 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05545501
The ClinicalTrials.gov registry entry for NCT05545501 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 3 interventions - of which No Salt, No β-OHB is the first listed.
NCT05545501 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Alabama, Indiana.
Frequently Asked Questions
What is clinical trial NCT05545501 about?
NCT05545501 is a clinical study titled "Ketone Ester and Salt (KEAS) in Young Adults". 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 ...
What is the current status of trial NCT05545501?
This trial is currently recruiting. It is a NA study. The enrollment target is 35 participants. The study started on 2023-03-24. Estimated completion is 2026-09-30.
What conditions does trial NCT05545501 study?
This clinical trial studies the following conditions: Hypertension, Salt; Excess.
What interventions are being tested in trial NCT05545501?
The interventions under investigation include: No Salt, No β-OHB (DIETARY_SUPPLEMENT), High Salt, No β-OHB (DIETARY_SUPPLEMENT), High Salt, High β-OHB (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05545501?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05545501 being conducted?
This trial has 2 study locations across Alabama, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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