Oral Nitrite Synthesis and Post-exercise Hypotension

Sponsor

University of Plymouth (Other)

Overall Status

Completed

CT.gov ID

NCT03904394

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure Sports Physical Therapy	Other: Exercise	N/A

Study Design

Study Type:

Interventional

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 :

Apr 20, 2018

Actual Study Completion Date :

Mar 11, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in blood pressure after exercise [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

Change in reactive hyperaemia [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratory of Nutrition, Exercise & Health	Plymouth	Devon	United Kingdom	PL4 8AA

Sponsors and Collaborators

University of Plymouth

Investigators

Principal Investigator: Crai Cutler, MSc, University of Plymouth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Raul Bescos, Director, University of Plymouth

ClinicalTrials.gov Identifier:

NCT03904394

Other Study ID Numbers:

(16/17)-666

First Posted:

Apr 5, 2019

Last Update Posted:

Apr 8, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Post-Exercise Hypotension

Hypotension

Study Results

No Results Posted as of Apr 8, 2019