Ketone Ester and Salt (KEAS) in Young Adults

Part of paid clinical trials in Auburn, Alabama.

Sponsor
Indiana University
Study ID
NCT05545501
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • No Salt, No β-OHB — DIETARY_SUPPLEMENT
    Participants will consume the following for ten days. Enteric capsules will be filled with a dextrose placebo. The placebo supplement will be a β-OHB-free, taste and viscosity-matched, beverage produced by KetoneAid.
  • High Salt, No β-OHB — DIETARY_SUPPLEMENT
    Participants will consume the following for ten days. Enteric capsules will be filled with Morton's table salt. Sodium consumption will be normalized to caloric intake (2 mg Sodium/Calorie). The placebo supplement will be a β-OHB-free, taste and viscosity-matched, beverage produced by KetoneAid.
  • High Salt, High β-OHB — DIETARY_SUPPLEMENT
    Participants will consume the following for ten days. Enteric capsules will be filled with Morton's table salt. Sodium consumption will be normalized to caloric intake (2 mg Sodium/Calorie). Ketone beverage will be the β-OHB supplement produced by KetoneAid. Participants will consume 24 mL (12 grams β-OHB) of the ketone beverage three times a day (total 36 grams β-OHB).

Study Details

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.

Key Dates

Start date
Mar 24, 2023
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Placebo/Placebo, then Salt/Placebo, then Salt/Ketone
    Participants will consume each of the supplement combinations 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. A washout period will be required prior to starting each of the next two supplement combination assignments.
  • Active Comparator: Salt/Placebo, then Salt/Ketone, then Placebo/Placebo
    Participants will consume each of the supplement combinations 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. A washout period will be required prior to starting each of the next two supplement combination assignments.
  • Active Comparator: Salt/Ketone, then Placebo/Placebo, then Salt/Placebo
    Participants will consume each of the supplement combinations 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. A washout period will be required prior to starting each of the next two supplement combination assignments.

Primary Outcome Measure

Blood pressure reactivity responses [ Time Frame: This measure is completed on day 10 of each 10-day intervention (low salt, high salt, high salt+ ketone) over 3-4 months and values will be compared across interventions. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Auburn UniversityAuburnAlabama36849-
Indiana University, School of Public HealthBloomingtonIndiana47405
Austin T Robinson, PhD
[email protected]
574-514-1034

Find similar trials in Auburn, AL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Auburn University· Auburn, ALIndiana University, School of Public Health· Bloomington, IN

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