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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 39
Healthy Volunteers: t
View:

• Between the ages of 19-39

• 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, \& 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).

Locations
United States
Alabama
Auburn University
COMPLETED
Auburn
Indiana
Indiana University, School of Public Health
RECRUITING
Bloomington
Contact Information
Primary
Austin T Robinson, PhD
ausrobin@iu.edu
15745141034
Backup
Braxton A Linder, MS
Time Frame
Start Date: 2023-03-24
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 35
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Missouri-Columbia, University of Utah
Leads: Indiana University

This content was sourced from clinicaltrials.gov