Ketone Ester And Salt (KEAS) in Older Adults

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT06868719
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 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 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.

Key Dates

Start date
Mar 6, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 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 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.
  • Active Comparator: Salt/Placebo, then Salt/Ketone, then Placebo/Placebo
    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.
  • Active Comparator: Salt/Ketone, then Placebo/Placebo, then Salt/Placebo
    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.

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 (1)

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

Find similar trials in Bloomington, IN

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

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