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Oral Nitrite Synthesis and Post-exercise Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03904394
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : April 8, 2019
Information provided by (Responsible Party):
Raul Bescos, University of Plymouth

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Sports Physical Therapy Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Impact of Nitrate-reducing Capacity of Oral Bacteria on Post-exercise Hypotension in Healthy Individuals.
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : March 11, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Mouthwash Other: Exercise
Four sets of 7 minutes at 65% of VO2peak interspersed with 3 min of passive recovery

Active Comparator: Antibacterial Mouthwash Other: Exercise
Four sets of 7 minutes at 65% of VO2peak interspersed with 3 min of passive recovery

Primary Outcome Measures :
  1. Change in blood pressure after exercise [ Time Frame: Baseline and 1 hour and 2 hours 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.

Secondary Outcome Measures :
  1. Change in reactive hyperaemia [ Time Frame: Baseline and 1 hour and 2 hours after exercise ]
    Tissue oxygenation index (TOI) were recorded on the left forearm (extensor digitorum) using a NIRS system (NIRO-200NX, Hamamatsu) before exercise and 2 hours after exercise. After baseline measurements (2 minutes), an automatic pneumatic cuff (Hokanson E-20 AG101) was inflated ~5cm above the elbow for 5 minutes to an occlusion pressure of 200 mmHg. Then, inflation of the cuff was rapidly released (< 1 second) and the NIRS measurements were continuously monitored for 5 minutes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Blood pressure (SBP < 130 mmHg; DBP < 90 mmHg) BMI < 30 kg/m2 Age 18 to 50 years old

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03904394

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United Kingdom
Laboratory of Nutrition, Exercise & Health
Plymouth, Devon, United Kingdom, PL4 8AA
Sponsors and Collaborators
University of Plymouth
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Principal Investigator: Crai Cutler, MSc University of Plymouth
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Responsible Party: Raul Bescos, Director, University of Plymouth Identifier: NCT03904394    
Other Study ID Numbers: (16/17)-666
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Information will be available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Exercise Hypotension
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases