Oral Nitrite Synthesis and Post-exercise Hypotension

Blood Pressure Clinical Trial

Official title:

The Impact of Nitrate-reducing Capacity of Oral Bacteria on Post-exercise Hypotension in Healthy Individuals.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03904394
• Other study ID #: (16/17)-666
• Status: Completed
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: March 11, 2019

Study information

• Verified date: April 2019
• Source: University of Plymouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 11, 2019
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypotension
• Post-Exercise Hypotension
• Sports Physical Therapy

Intervention

Other:
• Exercise
Four sets of 7 minutes at 65% of VO2peak interspersed with 3 min of passive recovery

Locations

Country	Name	City	State
United Kingdom	Laboratory of Nutrition, Exercise & Health	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and 1 hour and 2 hours after exercise