RECRUITING

Ketone Ester And Salt (KEAS) in Older Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-06
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06868719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 50-85
  2. * Resting blood pressure no higher than 150/90
  3. * BMI below 35 kg/m2 (or otherwise healthy)
  4. * Free of any metabolic disease (diabetes or renal), pulmonary disorders (COPD or cystic fibrosis), cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular), no autoimmune diseases, and no history of cancer
  5. * Do not have any precluding medical conditions (i.e. hemophilia) or medication (Pradaxa, Eliquis, etc.) that prevent participants from giving blood
  6. * Participants must be able to cycle on an exercise bike for up to one hour at a time.
  1. * High blood pressure - greater the150/90 mmHg
  2. * Low blood pressure - less than 90/50 mmHg
  3. * History of cardiovascular disease
  4. * History of cancer
  5. * History of diabetes
  6. * History of kidney disease
  7. * Obesity (BMI \> 30 kg/m2)
  8. * Smoking or tobacco use
  9. * Current pregnancy
  10. * Nursing mothers

Contacts and Locations

Study Contact

Austin T Robinson, PhD
CONTACT
5745141034
ausrobin@iu.edu
Braxton A Linder, PhD
CONTACT
2568567599
balinder@iu.edu

Study Locations (Sites)

School of Public Health
Bloomington, Indiana, 47405
United States

Collaborators and Investigators

Sponsor: Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-06
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-03-06
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Blood Pressure
  • Salt
  • Aging
  • Inflammation
  • Cardiovascular Disease

Additional Relevant MeSH Terms

  • Salt; Excess
  • Hypertension
  • Aging
  • Inflammation
  • Blood Pressure