Effects of Acute Dietary Sodium on Cerebrovascular Reactivity and Blood Pressure Reactivity

• Sponsor: University of Delaware (Other)
• Overall Status: Completed
• CT.gov ID: NCT03564262
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 25
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure; Cerebrovascular Reactivity	Other: Low Sodium Meal (138 mg sodium); Other: High Sodium Meal (1,495 mg sodium)	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Effects of Acute Dietary Sodium on Cerebrovascular Reactivity and Blood Pressure Reactivity
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cerebrovascular Reactivity Cerebrovascular reactivity (CVR) will be assessed using transcranial Doppler ultrasound with carbon dioxide as the vasoactive stimuli. The intervention is to provide subjects with either a low sodium meal (138 mg sodium) and high sodium meal (1,495 mg sodium), in a randomized order. The CVR test will be performed prior to soup consumption as well as after soup consumption.	Other: Low Sodium Meal (138 mg sodium); One Low Sodium Meal; Other: High Sodium Meal (1,495 mg sodium); One High Sodium Meal
Experimental: Blood Pressure Reactivity Blood pressure responses during dynamic exercise will be assessed. The intervention is to provide subjects with either a low sodium meal (138 mg sodium) and high sodium meal (1,495 mg sodium), in a randomized order. Blood pressure reactivity during dynamic exercise will be assessed after soup consumption.	Other: Low Sodium Meal (138 mg sodium); One Low Sodium Meal; Other: High Sodium Meal (1,495 mg sodium); One High Sodium Meal

Outcome Measures

Primary Outcome Measures

1. Change from Baseline Cerebrovascular Reactivity post soup consumption [Prior to and 60 minutes after soup consumption]

   Middle Cerebral Artery/ End-tidal Carbon Dioxide (cm/s/mmHg)

2. Blood Pressure Reactivity- Dynamic Exercise [80 minutes after soup consumption]

   Change in Blood Pressure during dynamic exercise (mmHg)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	William B Farquhar	Newark	Delaware	United States	19713

Sponsors and Collaborators

• University of Delaware

Investigators

• Principal Investigator: William B Farquhar, PhD, University of Delaware
• Principal Investigator: Kamila U Migdal, BS, University of Delaware

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Farquhar, Professor, University of Delaware
• ClinicalTrials.gov Identifier: NCT03564262
• Other Study ID Numbers: 1178955-1
• First Posted: Jun 20, 2018
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 22, 2020