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

NCT03558022 | Completed

• 1 other identifier: HM20013060
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Salt Pills

EXPERIMENTAL

One week on low salt diet plus salt pills

Dietary Supplement: Salt Pills

Placebo Pills

PLACEBO COMPARATOR

One week on low salt diet plus placebo pills

Dietary Supplement: Placebo Pills

Interventions

Salt Pills DIETARY_SUPPLEMENT

7 days of a low sodium diet plus 4 salt pills (sodium chloride) taken 3 times daily with meals (approximately 7000 milligrams per day)

Salt Pills

Placebo Pills DIETARY_SUPPLEMENT

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

Placebo Pills

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ryan Garten, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: May 15, 2018
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

US (1)