Oral Nitrite Synthesis and Post-exercise Hypotension
The Impact of Nitrate-reducing Capacity of Oral Bacteria on Post-exercise Hypotension in Healthy Individuals.
1 other identifier
interventional
23
1 country
1
Brief Summary
Exercise is probably the most effective approach to reduce blood pressure. In fact, a single bout of exercise induces a physiological response known as Post-Exercise Hypotension (PEH) where a prolonged decrease in resting blood pressure occurs in the minutes and hours after exercise. However, it is not fully understood how this response triggers. Recent evidence suggests that oral bacteria may play a key role in blood pressure control by enhancing nitrite, and then nitric oxide (NO) bioavailability under resting conditions in humans. However, no previous study has investigated whether this is a key mechanism involve in PEH. Thus, the main aim of this study was to investigate if the oral nitrate/nitrite pathway is a key regulator of PEH and vasodilation in healthy humans.
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 2017
Typical duration for not_applicable
1 active site
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 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2019
CompletedFirst Submitted
Initial submission to the registry
April 3, 2019
CompletedFirst Posted
Study publicly available on registry
April 5, 2019
CompletedApril 8, 2019
April 1, 2019
12 months
April 3, 2019
April 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in blood pressure after exercise
Blood pressure was measured before and at 1 hour and 2hours after exercise using an electronic sphygmomanometer (ProBP 3400, Welch Allyn). The second and third readings will be averaged to determine mean blood pressure.
Baseline and 1 hour and 2 hours after exercise
Secondary Outcomes (1)
Change in reactive hyperaemia
Baseline and 1 hour and 2 hours after exercise
Study Arms (2)
Placebo Mouthwash
PLACEBO COMPARATORAntibacterial Mouthwash
ACTIVE COMPARATORInterventions
Four sets of 7 minutes at 65% of VO2peak interspersed with 3 min of passive recovery
Eligibility Criteria
You may qualify if:
- Blood pressure (SBP \< 130 mmHg; DBP \< 90 mmHg) BMI \< 30 kg/m2 Age 18 to 50 years old
You may not qualify if:
- Smoker Hypertension Dyslipidaemia Diabetes Gingivitis or periodontitis Using antibacterial mouthwash or tongue scrapes Taking antibiotics 1 month before the start of the study Females without have irregular menstrual periods
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Nutrition, Exercise & Health
Plymouth, Devon, PL4 8AA, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Crai Cutler, MSc
University of Plymouth
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
- Director
Study Record Dates
First Submitted
April 3, 2019
First Posted
April 5, 2019
Study Start
May 9, 2017
Primary Completion
April 20, 2018
Study Completion
March 11, 2019
Last Updated
April 8, 2019
Record last verified: 2019-04