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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03564262
Other study ID # 1178955-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date June 1, 2020

Study information

Verified date September 2020
Source University of Delaware
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Americans eat more salt than is recommended by the American Heart Association. This is important because consuming a high-salt diet is associated with an increased risk of cardiovascular events, like strokes and heart attacks. In fact, consuming one high-salt meal temporarily reduces blood vessel function and it is not uncommon for Americans to consume high-salt meals. Therefore, our laboratory is interested in determining if a single high-salt meal affects 1) brain blood vessel function at rest and 2) blood pressure responses during exercise.


Description:

Excess dietary salt increases the risk of cardiovascular events like strokes and heart attacks, independent of resting blood pressure. Recent data found that consuming one high-salt meal temporarily reduces endothelial function in the periphery. This decrease in endothelial function can lead to an exaggerated blood pressure response during exercise and may also attenuate cerebrovascular reactivity at rest. This is essential, because an exaggerated cardiovascular response to exercise and a decrease in brain blood vessel function at rest are risk factors for future cardiovascular events. The long-term goal is to determine how dietary salt adversely affects BP and cerebrovascular regulation. The objective of this proposal is to evaluate the impact of an acute dietary salt meal on BP response during exercise and cerebrovascular reactivity at rest. The investigators have 2 specific aims: 1) Aim 1 will test the hypothesis that high dietary salt will reduce cerebrovascular reactivity, 2) Aim 2 will test the hypothesis that high dietary salt will augment blood pressure reactivity during exercise. The findings of this project will shed light on how acute dietary salt affects the risk of cardiovascular events during a bout of exercise and long-term risk for cardiovascular disease and stroke.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- normal blood pressure

- males, females, minorities

Exclusion Criteria:

- high blood pressure

- body mass index (BMI > 30 kg/m2)

- smokers or nicotine users

- those who are pregnant or planning to become pregnant

- allergy to the tomato soup

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Low Sodium Meal (138 mg sodium)
One Low Sodium Meal
High Sodium Meal (1,495 mg sodium)
One High Sodium Meal

Locations

Country Name City State
United States William B Farquhar Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

References & Publications (1)

Migdal KU, Robinson AT, Watso JC, Babcock MC, Serrador JM, Farquhar WB. A high-salt meal does not augment blood pressure responses during maximal exercise. Appl Physiol Nutr Metab. 2020 Feb;45(2):123-128. doi: 10.1139/apnm-2019-0217. Epub 2019 Jun 25. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Cerebrovascular Reactivity post soup consumption Middle Cerebral Artery/ End-tidal Carbon Dioxide (cm/s/mmHg) Prior to and 60 minutes after soup consumption
Primary Blood Pressure Reactivity- Dynamic Exercise Change in Blood Pressure during dynamic exercise (mmHg) 80 minutes after soup consumption
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