Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake

Hypertension Clinical Trial

Official title:

Vascular Responses to Sympathetic Activation and Altered Shear Rate: The Impact of Hypertension and Sodium Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558022
• Other study ID #: HM20013060
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: November 5, 2021

Study information

• Verified date: January 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine if alterations in sodium intake alter peripheral vascular function and exercise tolerance in young individuals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 5, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• 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 Pills
7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Dilation in Response to Exercise	Percent change is arterial diameter when compared to baseline	After 7 day high salt supplementation vs After 7 day low salt supplementation