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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03565653
Other study ID # 1085139
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date July 1, 2019

Study information

Verified date September 2019
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The new American Heart Association (AHA) blood pressure guidelines are expected to raise the prevalence of high blood pressure to ~46% in the United States. One recommendation for lowering blood pressure is aerobic exercise, which produces a period of lowered blood pressure (post-exercise hypotension; PEH) that lasts up to 24 hours. It is believed that PEH may be responsible for the observations of lowered blood pressure following initiation of exercise. However, most Americans eat too much salt, which expands plasma volume and may prevent PEH, rending aerobic exercise ineffective in improving blood pressure status.


Description:

Recently released blood pressure guidelines from the American Heart Association and American College of Cardiology are expected to raise the prevalence of hypertension in America from ~33% to ~46%. A single bout of aerobic exercise produces a prolonged period (up to 24 hours) of lowered blood pressure (post-exercise hypotension; PEH). Repeated bouts of aerobic exercise results in maintenance of lowered blood pressure, leading to recommendations of aerobic exercise for improvement of blood pressure status. However, more than 90% of Americans consume more sodium in their diets than is recommended. This is alarming, as excess dietary sodium intake expands plasma fluid volume, which may in turn attenuate the reduction in BP following exercise. Therefore, the objective of this project is to determine the effects of high dietary sodium intake on PEH. The investigators hypothesize that, compared to a recommended sodium diet, a high salt diet will attenuate post-exercise hypotension.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 1, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Recreationally active

Exclusion Criteria:

- high blood pressure (>140/90 mmHg)

- history of cardiovascular disease

- history of cancer

- history of diabetes

- history of kidney disease

- obesity (BMI > 30 kg/m2)

- smoking or tobacco use

- current pregnancy

- nursing mothers

- communication barriers

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High dietary salt
~4,000 mg Na+/day
Placebo
dextrose

Locations

Country Name City State
United States Department of Kinesiology and Applied Physiology, University of Delaware Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-exercise hypotension Change in mean arterial pressure from pre- to post-exercise 24 hours following exercise
Secondary Blood pressure reactivity Change in mean, systolic, and diastolic blood pressure from baseline to exercise 10th day of high salt diet
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