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The Effects of Dietary Salt on Post-exercise Hypotension

Primary Purpose

Blood Pressure, Post-Exercise Hypotension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High dietary salt
Placebo
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Blood Pressure

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Kinesiology and Applied Physiology, University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High dietary salt

Placebo

Arm Description

For 10 days each, participants will be asked to eat a recommended sodium diets (2300 mg Na+/d) while taking unmarked pills containing uniodized table salt. On the 10th day, participants will report to the lab to complete 60 minutes of cycling exercise. Following exercise, participants will rest for 60 minutes while undergoing serial blood pressure measurements. Participants will then be outfitted with ambulatory blood pressure cuffs for assessment of blood pressure over the following 24 hours.

For 10 days each, participants will be asked to eat a recommended sodium diets (2300 mg Na+/d) while taking unmarked pills containing a placebo (dextrose). Participants will complete both interventions in random order. On the 10th day, participants will report to the lab to complete 60 minutes of cycling exercise. Following exercise, participants will rest for 60 minutes while undergoing serial blood pressure measurements. Participants will then be outfitted with ambulatory blood pressure cuffs for assessment of blood pressure over the following 24 hours.

Outcomes

Primary Outcome Measures

Post-exercise hypotension
Change in mean arterial pressure from pre- to post-exercise

Secondary Outcome Measures

Blood pressure reactivity
Change in mean, systolic, and diastolic blood pressure from baseline to exercise

Full Information

First Posted
June 11, 2018
Last Updated
September 27, 2019
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT03565653
Brief Title
The Effects of Dietary Salt on Post-exercise Hypotension
Official Title
The Effects of Dietary Salt on Post-exercise Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Post-Exercise Hypotension

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dietary salt
Arm Type
Experimental
Arm Description
For 10 days each, participants will be asked to eat a recommended sodium diets (2300 mg Na+/d) while taking unmarked pills containing uniodized table salt. On the 10th day, participants will report to the lab to complete 60 minutes of cycling exercise. Following exercise, participants will rest for 60 minutes while undergoing serial blood pressure measurements. Participants will then be outfitted with ambulatory blood pressure cuffs for assessment of blood pressure over the following 24 hours.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
For 10 days each, participants will be asked to eat a recommended sodium diets (2300 mg Na+/d) while taking unmarked pills containing a placebo (dextrose). Participants will complete both interventions in random order. On the 10th day, participants will report to the lab to complete 60 minutes of cycling exercise. Following exercise, participants will rest for 60 minutes while undergoing serial blood pressure measurements. Participants will then be outfitted with ambulatory blood pressure cuffs for assessment of blood pressure over the following 24 hours.
Intervention Type
Other
Intervention Name(s)
High dietary salt
Intervention Description
~4,000 mg Na+/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
dextrose
Primary Outcome Measure Information:
Title
Post-exercise hypotension
Description
Change in mean arterial pressure from pre- to post-exercise
Time Frame
24 hours following exercise
Secondary Outcome Measure Information:
Title
Blood pressure reactivity
Description
Change in mean, systolic, and diastolic blood pressure from baseline to exercise
Time Frame
10th day of high salt diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Kinesiology and Applied Physiology, University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Dietary Salt on Post-exercise Hypotension

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