NCT03565653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

June 11, 2018

Last Update Submit

September 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-exercise hypotension

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

    24 hours following exercise

Secondary Outcomes (1)

  • Blood pressure reactivity

    10th day of high salt diet

Study Arms (2)

High dietary salt

EXPERIMENTAL

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

Placebo

EXPERIMENTAL

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

\~4,000 mg Na+/day

High dietary salt
PlaceboOTHER

dextrose

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreationally active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Post-Exercise Hypotension

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 21, 2018

Study Start

May 1, 2018

Primary Completion

June 30, 2019

Study Completion

July 1, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations