High Salt Intake for High Blood Pressure

(KEAS-O Trial)

Overseen By Braxton A Linder, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Must not be taking: Pradaxa, Eliquis

Disqualifiers: Hypertension, Cancer, Diabetes, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ketone supplements (KEAS) can protect against the negative effects of excessive salt intake, such as high blood pressure and kidney problems. Researchers aim to determine if these supplements improve heart and kidney health by reducing inflammation and enhancing blood flow. Participants will undergo different phases, including taking a placebo (a harmless pill with no active ingredient) and consuming salt with or without ketones, to observe bodily reactions. Individuals aged 60 to 85 with controlled blood pressure (not exceeding 150/90) and no major health issues like diabetes or heart disease may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to better solutions for heart and kidney health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on blood thinners or have conditions that prevent safe exercise, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketone supplements are generally safe for people. Studies have found that ketone salts, a type of supplement, can lower blood pressure in adults over a few weeks. Another study found that these supplements do not cause serious side effects in healthy individuals. They increase blood ketone levels without major problems. However, in some cases, a slight increase in blood pressure occurred after taking ketone supplements. Overall, these supplements are usually well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of KEAS for high blood pressure because it introduces a new approach by combining dietary salt intake with ketones, which isn't common in standard treatments like ACE inhibitors, beta-blockers, or diuretics. Unlike typical medications that target different pathways to lower blood pressure, KEAS leverages nutritional interventions to potentially influence blood pressure and overall cardiovascular health. This unique combination might offer additional benefits by affecting inflammation and immune responses, which could lead to a more holistic approach to managing high blood pressure.

What evidence suggests that ketone supplementation could be effective for high blood pressure?

Research has shown that ketone supplements might help with high blood pressure, particularly when linked to high salt intake. In rodent studies, these supplements prevented blood pressure increases and protected blood vessels and kidneys from salt-related damage. Some human studies found that ketone salts can lower systolic blood pressure in healthy individuals. Evidence also suggests that a ketone compound called β-OHB might lower blood pressure by improving blood vessel function and supporting the heart. However, some studies indicate that ketone supplements might not significantly affect blood pressure. This trial will further explore these effects by testing different combinations of salt and ketone supplements across various treatment arms. While early results are promising, more research is needed to confirm these effects in humans. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Current pregnancy

High blood pressure - greater than 150/90 mmHg

Low blood pressure - less than 90/50 mmHg

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• KEAS

Trial Overview The 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.

How Is the Trial Designed?

Group I: Placebo/Placebo, then Salt/Placebo, then Salt/Ketone Active Control 3 Interventions

Participants will consume each of the supplemental interventions for 10 days (in this assigned order). On Day 10 of each interventional condition, 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. After a washout period, participants will consume the next assigned supplemental intervention for 10 days, and repeat the Day 10 assessments. After another washout period, participants will consume the final assigned supplemental intervention for 10 days, and again repeat the Day 10 assessments.

Group II: Salt/Placebo, then Salt/Ketone, then Placebo/Placebo Active Control 3 Interventions

Participants will consume each of the supplemental interventions for 10 days (in this assigned order). On day 10 of each interventional condition, 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. After a washout period, participants will consume the next assigned supplemental intervention for 10 days, and repeat the Day 10 assessments. After another washout period, participants will consume the final assigned supplemental intervention for 10 days, and again repeat the Day 10 assessments.

Group III: Salt/Ketone, then Placebo/Placebo, then Salt/Placebo Active Control 3 Interventions

Participants will consume each of the supplemental interventions for 10 days (in this assigned order). On day 10 of each interventional condition, 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. After a washout period, participants will consume the next assigned supplemental intervention for 10 days, and repeat the Day 10 assessments. After another washout period, participants will consume the final assigned supplemental intervention for 10 days, and again repeat the Day 10 assessments.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05545501

Ketone Ester and Acute Salt (KEAS) in Young Adults Additionally published rodent data indicates that ketone supplements prevent high salt-induced increases in blood pressure, blood vessel dysfunction, and kidney ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9733433/

The janus face of ketone bodies in hypertension - PMC For example, 6 weeks of ketone salt supplementation modestly reduced blood pressure in young adults [53]. Another study demonstrated that 2 weeks of ketone ...

3. ahajournals.org ahajournals.org/doi/10.1161/circ.145.suppl_1.EP40

Abstract EP40: Effects Of Ketone Salt Supplementation On ... Exogenous ketone salt supplementation has been shown to decrease systolic blood pressure (SBP) in healthy populations. Therefore, the primary ...

4. withpower.com withpower.com/trial/phase-hypertension-9-2022-9035d

Ketone Supplements for High Blood Pressure (KEAS Trial) The treatment β-OHB (a ketone body) is unique because it may lower blood pressure by reducing vascular resistance and improving heart function without the side ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/19390211.2023.2289961

Effect of Acute and Chronic Ingestion of Exogenous Ketone ... Based on currently available data, acute or prolonged ingestion of ketone supplements does not seem to modulate BP.

6. journalofmetabolichealth.org journalofmetabolichealth.org/index.php/jmh/article/view/47/171

Blood and cardiovascular health parameters after ... Conclusion: Chronic KS supplementation seems safe, significantly elevates blood ketone levels 30 and 60 min after supplementation and may lower blood pressure.

7. nature.com nature.com/articles/s44161-023-00259-1

Ketones and the cardiovascular system Administration of ketones to healthy fasting individuals results in an increase in systolic blood pressure, heart rate, biventricular function, ...

8. researchgate.net researchgate.net/publication/376643027_The_Impact_of_Ketone_Salt_Supplementation_on_Blood_Pressure_and_Health_Parameters_in_Adults_Diagnosed_with_PTSD_-A_Pilot_Study

The Impact of Ketone Salt Supplementation on Blood ... Results: Systolic blood pressure was significantly lower (p < 0.05) after supplementing with KS for 6 weeks but not PLA. All other health ...