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CompletedNCT03565653Updated Oct 1, 2019

The Effects of Dietary Salt on Post-exercise Hypotension

An interventional study of High dietary salt and Placebo in Blood Pressure and Post-Exercise Hypotension, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by University of Delaware · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Blood Pressure
  • Post-Exercise Hypotension
03

In context

Post-Exercise Hypotension

22 studies on the registry are indexed under Post-Exercise Hypotension; 2 are open to participants now.

This study's enrollment of 20 is close to the median of 21 across 22 interventional studies indexed under Post-Exercise Hypotension.

Browse Post-Exercise Hypotension studies →

Lead sponsor

University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Recreationally active

Exclusion criteria

Exclusion Criteria:

  • high blood pressure (>140/90 mmHg)
  • history of cardiovascular disease
  • history of cancer
  • history of diabetes
  • history of kidney disease
  • obesity ( > 30 kg/m2)
  • smoking or tobacco use
  • current pregnancy
  • nursing mothers
  • communication barriers
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • 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.

    Other: High dietary salt

  • 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.

    Other: Placebo

Interventions

  • OtherHigh dietary salt

    \~4,000 mg Na+/day

  • OtherPlacebo

    dextrose

06

What researchers measure

Primary outcomes

  1. Post-exercise hypotension

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

    Time frame: 24 hours following exercise

Secondary outcomes

  1. Blood pressure reactivity

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

    Time frame: 10th day of high salt diet

07

Study locations

1 site
  • Department of Kinesiology and Applied Physiology, University of Delaware
    Newark, Delaware 19713, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03565653
Responsible party
William Farquhar (Professor, University of Delaware) — Principal investigator
First posted
Jun 21, 2018
Start date
May 1, 2018
Primary completion
Jun 30, 2019
Completion
Jul 1, 2019
Last update
Oct 1, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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