The Effects of Dietary Salt on Post-exercise Hypotension
1 other identifier
interventional
20
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedOctober 1, 2019
September 1, 2019
1.2 years
June 11, 2018
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
EXPERIMENTALFor 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.
Placebo
EXPERIMENTALFor 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.
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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