- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558022
Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake
January 12, 2023 updated by: Virginia Commonwealth University
The aim of this study is to determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sodium intake is a major contributor to the development of hypertension in the developed world.
Interestingly, it has been recently revealed that, in addition to the cardiovascular dysfunction associated with high sodium intake-induced hypertension, individuals who have unaltered blood pressure after chronic high sodium intake, termed salt resistant, report similar reductions in cardiovascular function when compared to salt sensitive individuals.
While the extent to which this high sodium intake negatively alters cardiovascular structure as well as function is currently being explored, little is known about how high sodium intake impacts vascular function and blood flow regulation during exercise.
Therefore, this study will determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals.
The investigators hypothesize that increases in sodium intake will reduce exercise-induced arterial dilation in response to shear and result in exercise intolerance, via impaired functional sympatholysis, at moderate-to-high exercise workloads.
Furthermore, the investigators hypothesize that these changes in blood flow regulation and exercise tolerance in young individuals will be reversed following antioxidant supplementation, implicating the role of oxidative stress in this dysfunction.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- normotensive blood pressure (Systolic <120 AND Diastolic <80
- free of cardiovascular disease and any evidence of thyroid, renal, metabolic, pulmonary or neurological disease
- non-obese (BMI <30 and/or Body fat < 25% for men, and < 30% for women)
- no tobacco use
- no medications that could affect vascular function or oxidative stress
- not sedentary
Exclusion Criteria:
- individual with cardiovascular, pulmonary, or metabolic disease or taking medications that may alter cardiovascular, pulmonary, or metabolic function
- subjects will be asked to maintain a dietary record for one week subsequent to the pre-screening and if this reveals a diet that differs substantially from the "typical" average diet, the subject will not be eligible
- subjects will be excluded from the study if dietary records reveal significant caloric restriction and/or vitamin/mineral deficiencies
- pregnant women, prisoners, and children will not be eligible for this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Salt Pills
One week on low salt diet plus salt pills
|
7 days of a low sodium diet plus 4 salt pills (sodium chloride) taken 3 times daily with meals (approximately 7000 milligrams per day)
|
Placebo Comparator: Placebo Pills
One week on low salt diet plus placebo pills
|
7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arterial Dilation in Response to Exercise
Time Frame: After 7 day high salt supplementation vs After 7 day low salt supplementation
|
Percent change is arterial diameter when compared to baseline
|
After 7 day high salt supplementation vs After 7 day low salt supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ryan Garten, PhD, Virginia Commonwealth 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 Major Dates
Study Start (Actual)
May 15, 2018
Primary Completion (Actual)
November 5, 2021
Study Completion (Actual)
November 5, 2021
Study Registration Dates
First Submitted
June 4, 2018
First Submitted That Met QC Criteria
June 4, 2018
First Posted (Actual)
June 15, 2018
Study Record Updates
Last Update Posted (Estimate)
January 13, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20013060
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
BayerCompletedPrimary HypertensionChina
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Addpharma Inc.Completed
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on Salt Pills
-
Singapore Institute of TechnologyAMILI Pte. Ltd.Active, not recruitingGastrointestinal Microbiome | Protein DigestionSingapore
-
Beijing Tiantan HospitalTasly Pharmaceutical Group Co., LtdActive, not recruiting
-
China National Center for Cardiovascular DiseasesFuwai Yunnan Cardiovascular HospitalRecruitingCoronary Heart Disease | Medicine, Chinese TraditionalChina
-
University of Maryland, BaltimoreNot yet recruitingChronic Pain | Headache
-
Tasly Pharmaceutical Group Co., LtdCompleted
-
Dalian UniversityUnknown
-
Dongzhimen Hospital, BeijingNot yet recruiting
-
Guangzhou University of Traditional Chinese MedicineNot yet recruitingAcute Coronary Syndrome
-
Tasly Pharmaceuticals, Inc.UnknownNon-small Cell Lung Cancer (NSCLC)China