~20 spots leftby Dec 2027

High Salt Intake for High Blood Pressure

(KEAS-O Trial)

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Must not be taking: Pradaxa, Eliquis
Disqualifiers: Hypertension, Cancer, Diabetes, Obesity, others

Trial Summary

What is the purpose of this trial?

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

This trial is for older adults who may be experiencing high blood pressure and are at risk of developing complications like kidney disease or cardiovascular issues due to high salt intake. Participants should not have any conditions that would exclude them from the study.

Inclusion Criteria

Resting blood pressure no higher than 150/90
I am between 50 and 85 years old.
I can cycle on an exercise bike for up to an hour.
See 3 more

Exclusion Criteria

Current pregnancy
High blood pressure - greater than 150/90 mmHg
Low blood pressure - less than 90/50 mmHg
See 7 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants undergo baseline assessments including sleep, physical activity, and dietary intake

14 days
Participants wear ActiGraph devices and complete diet logs

Intervention

Participants consume the supplemental intervention for 10 days with assessments on day 10

10 days
1 visit (in-person) on day 10 for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • KEAS (Dietary Supplement)
Trial OverviewThe study tests if ketone supplements can prevent negative effects of a high-salt diet in older adults, such as increased blood pressure, poor blood vessel function, and kidney damage. It involves comparing different combinations of salt and β-OHB (a type of ketone) intake.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: High Salt, High β-OHBExperimental Treatment1 Intervention
Participants will consume the supplemental intervention for 10 days. On day 10 participants will arrive at the laboratory where the investigators will assess resting blood pressure, arterial stiffness, endothelial function, renal blood flow, and submaximal exercise blood pressure reactivity. Blood will be collected to investigate inflammatory and immune responses to the dietary conditions. Starting on day 9, participants will undergo ambulatory blood pressure monitoring and 24-hour urine collection.
Group II: High Salt, No β-OHBActive Control1 Intervention
Participants will consume the supplemental intervention for 10 days. On day 10 participants will arrive at the laboratory where the investigators will assess resting blood pressure, arterial stiffness, endothelial function, renal blood flow, and submaximal exercise blood pressure reactivity. Blood will be collected to investigate inflammatory and immune responses to the dietary conditions. Starting on day 9, participants will undergo ambulatory blood pressure monitoring and 24-hour urine collection.
Group III: No Salt, No β-OHBPlacebo Group1 Intervention
Participants will consume the supplemental intervention for 10 days. On day 10 participants will arrive at the laboratory where the investigators will assess resting blood pressure, arterial stiffness, endothelial function, renal blood flow, and submaximal exercise blood pressure reactivity. Blood will be collected to investigate inflammatory and immune responses to the dietary conditions. Starting on day 9, participants will undergo ambulatory blood pressure monitoring and 24-hour urine collection.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
School of Public HealthBloomington, IN
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Who Is Running the Clinical Trial?

Indiana UniversityLead Sponsor
University of UtahCollaborator
University of Missouri-ColumbiaCollaborator
National Institute on Aging (NIA)Collaborator

References