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Ketone Ester And Salt (KEAS) in Older Adults

Ketone Supplementation as a Strategy to Reduce the Negative Health Effects of High Dietary Salt in Older Adults

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits
  • Procedures mentioned: Blood draws, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators will also measure inflammatory markers in blood samples and isolate immune cells that control inflammation."
  • "Though exploratory, the investigators hypothesize that β-OHB supplementation blunts the HS-induced proinflammatory alterations in monocytes and blood samples using parallel in vitro and applied approaches."
  • "Participants will report to the laboratory for four visits."
  • "Supplementation conditions include \[A\] Placebo capsules and Placebo beverage, \[B\] Salt capsules and Placebo beverage, and \[C\] Salt capsules and Ketone beverage."
  • "Participants will consume their placebo/salt capsules three times per day and their placebo/ketone beverage three times per day."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ketone supplements can protect against the effects of a high-salt diet in adults ages 60–85. Ketones are substances made by the liver. Researchers will study blood pressure, blood vessels, kidney health, and signs of inflammation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 60–85 years old.
  • Your blood pressure at rest is no higher than 150/90.
  • Your BMI (a measure of weight compared with height) is below 35, or you are otherwise healthy. The exclusion list gives a different BMI limit.
  • You have no diabetes, kidney disease, listed lung disorders, or heart or blood vessel disease.
  • You have no health problems that prevent safe exercise or giving blood.

Who can't join

  • Your blood pressure is higher than 150/90.
  • Your BMI is above 30. This differs from the limit in the inclusion list.
  • You have a history of diabetes or kidney disease.
  • You have a history of lung disorders, such as COPD (a long-term lung disease), severe asthma, or cystic fibrosis.
  • You have a history of heart or blood vessel disease, including disease affecting blood flow to the brain or limbs.
  • Health problems prevent safe exercise or giving blood, such as painful arthritis or taking blood thinners.
  • You have smoked, used smokeless tobacco, or vaped within the past 12 months.
  • You are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Between the ages of 60-85 * Resting blood pressure no higher than 150/90 * BMI below 35 kg/m2 (or otherwise healthy) * Free of any metabolic disease (diabetes or renal), pulmonary disorders (COPD, severe asthma, or cystic fibrosis), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular) * Do not have any precluding medical conditions that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners) Exclusion Criteria: * High blood pressure - greater than150/90 mmHg * Obesity (BMI \> 30 kg/m2) * History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, \& cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular). * Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) * Medical issues that prevent giving blood (e.g., blood thinners). * Current smoking, using smokeless tobacco, or vaping (within past 12 months) * Current pregnancy

Study sites (1)

IN