COMPLETED

Vascular Effects of Acute Sodium (VEAS) Study

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

This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998). About nine out of ten Americans overconsume dietary salt. Compared to other racial groups, Black individuals are more prone to salt-sensitive hypertension and negative cardiovascular conditions associated with high salt intake. However, there is a critical need to determine the reasons behind and mechanisms that contribute to these racial disparities. Both acute (single meal) and chronic high-dietary sodium cause small but important increases in blood sodium concentration that are associated with altered blood pressure regulation and blood vessel dysfunction. However, racial differences in these measures have not been examined. This is important because Black individuals generally exhibit lower circulating concentrations of hormones (e.g., renin, aldosterone, angiotensin 2) that buffer changes in body sodium to regulate blood pressure, and this could make them more vulnerable to the negative effects of a high-sodium meal. Therefore, the purpose of this study is to determine whether there are racial differences in blood pressure regulation and blood flow after a high-sodium meal. The investigators will assess blood pressure regulation, blood vessel stiffness, and the blood vessel's ability to dilate before and after a high-salt meal and a low-salt control meal (both meals are low-salt tomato soup with varied added salt). The investigators will also collect blood and urine to measure sodium and determine biochemical changes that may be contributing to racial differences in cardiovascular function.

Official Title

The Effects of a High Salt Meal on Blood Flow Regulation

Quick Facts

Study Start:2021-05-03
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04244604

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:19 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Are between the ages of 19-40.
  2. 2. Have blood pressure no higher than 140/90 mmHg.
  3. 3. Have a BMI below 35 Kg/m2 (otherwise healthy)
  4. 4. Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, or cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
  5. 5. Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).
  6. 6. Are not currently smoking, using smokeless tobacco, nor smoked within the past 12 months.
  1. 1. High blood pressure - greater than 140/90 mmHg
  2. 2. Obesity (BMI \> 30 kg/m2)
  3. 3. History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, or cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular)
  4. 4. Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis)
  5. 5. Medical issues that prevent giving blood (e.g., blood thinners)
  6. 6. Currently smoking, using smokeless tobacco, or vaping (within past 12 monrths)
  7. 7. Current pregnancy

Contacts and Locations

Study Locations (Sites)

Auburn University
Auburn, Alabama, 36849
United States
Indiana University 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 Date2021-05-03
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2021-05-03
Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

  • blood pressure
  • racial disparities
  • cardiovascular health
  • physical fitness
  • sleep
  • dietary sodium
  • dietary salt
  • diet

Additional Relevant MeSH Terms

  • Sodium Excess
  • Racial Disparities
  • Blood Pressure
  • Cardiovascular Risk Factor