- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03565653
The Effects of Dietary Salt on Post-exercise Hypotension
September 27, 2019 updated by: William Farquhar, University of Delaware
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Department of Kinesiology and Applied Physiology, University of Delaware
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High dietary salt
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.
|
~4,000 mg Na+/day
|
|
Experimental: Placebo
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.
|
dextrose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-exercise hypotension
Time Frame: 24 hours following exercise
|
Change in mean arterial pressure from pre- to post-exercise
|
24 hours following exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure reactivity
Time Frame: 10th day of high salt diet
|
Change in mean, systolic, and diastolic blood pressure from baseline to exercise
|
10th day of high salt diet
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
June 30, 2019
Study Completion (Actual)
July 1, 2019
Study Registration Dates
First Submitted
June 11, 2018
First Submitted That Met QC Criteria
June 11, 2018
First Posted (Actual)
June 21, 2018
Study Record Updates
Last Update Posted (Actual)
October 1, 2019
Last Update Submitted That Met QC Criteria
September 27, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1085139
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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