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Oral Nitrite Synthesis and Post-exercise Hypotension

Primary Purpose

Blood Pressure, Sports Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Blood Pressure

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Laboratory of Nutrition, Exercise & Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Mouthwash

Antibacterial Mouthwash

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in reactive hyperaemia
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.

Full Information

First Posted
April 3, 2019
Last Updated
April 4, 2019
Sponsor
University of Plymouth
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1. Study Identification

Unique Protocol Identification Number
NCT03904394
Brief Title
Oral Nitrite Synthesis and Post-exercise Hypotension
Official Title
The Impact of Nitrate-reducing Capacity of Oral Bacteria on Post-exercise Hypotension in Healthy Individuals.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 9, 2017 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
March 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Sports Physical Therapy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Mouthwash
Arm Type
Placebo Comparator
Arm Title
Antibacterial Mouthwash
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Four sets of 7 minutes at 65% of VO2peak interspersed with 3 min of passive recovery
Primary Outcome Measure Information:
Title
Change in blood pressure after exercise
Description
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.
Time Frame
Baseline and 1 hour and 2 hours after exercise
Secondary Outcome Measure Information:
Title
Change in reactive hyperaemia
Description
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.
Time Frame
Baseline and 1 hour and 2 hours after exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crai Cutler, MSc
Organizational Affiliation
University of Plymouth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Nutrition, Exercise & Health
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL4 8AA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Information will be available upon request

Learn more about this trial

Oral Nitrite Synthesis and Post-exercise Hypotension

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