Dietary Nitrate Intake in Vegetarians and Omnivores

NCT ID: NCT03871777

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-09

Study Completion Date

2018-11-12

Brief Summary

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Vegetarian diets are commonly associated with lower blood pressure levels. This has been related to greater consumption of inorganic nitrate, since vegetables are the main source of this anion. Dietary nitrate is reduced to nitrite by commensal bacteria in the mouth, which in turn leads to increased circulatory nitrite availability. Nitrite can form nitric oxide by several pathways promoting a reduction in the vascular tone and lower blood pressure.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Vegetarians

Healthy vegetarians (vegans and lacto-ovo vegetarians) 18 and 50 years formed this arm.

Group Type ACTIVE_COMPARATOR

Placebo mouthwash

Intervention Type OTHER

Participants received placebo mouthwash (ultrapure unflavoured water) with which they rinsed their mouth for one minute, twice a day for 7 days. Resting metabolic rate and blood pressure were measured on day eight. Additionally, blood and saliva samples were taken from all the participants. Dietary records of seven days were also collected in order to confirm the foods and portion sizes consumed, preparation methods, recipes and any brand names.

Chlorhexidine mouthwash

Intervention Type OTHER

After using placebo and complete all the physiological measurements, participants were given a further one-week supply of antibacterial mouthwash containing 0.2% chlorhexidine (Corsodyl, GlaxoSmithKline, UK), encouraged to rinse their mouth for one minute, twice a day for 7 more days. They returned to the laboratory in 7 days to repeat all measurements in the same order.

Omnivores

Healthy omnivores with similar characteristics of vegetarians (age, body mass index, gender and physical activity levels) formed this arm

Group Type SHAM_COMPARATOR

Placebo mouthwash

Intervention Type OTHER

Participants received placebo mouthwash (ultrapure unflavoured water) with which they rinsed their mouth for one minute, twice a day for 7 days. Resting metabolic rate and blood pressure were measured on day eight. Additionally, blood and saliva samples were taken from all the participants. Dietary records of seven days were also collected in order to confirm the foods and portion sizes consumed, preparation methods, recipes and any brand names.

Chlorhexidine mouthwash

Intervention Type OTHER

After using placebo and complete all the physiological measurements, participants were given a further one-week supply of antibacterial mouthwash containing 0.2% chlorhexidine (Corsodyl, GlaxoSmithKline, UK), encouraged to rinse their mouth for one minute, twice a day for 7 more days. They returned to the laboratory in 7 days to repeat all measurements in the same order.

Interventions

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Placebo mouthwash

Participants received placebo mouthwash (ultrapure unflavoured water) with which they rinsed their mouth for one minute, twice a day for 7 days. Resting metabolic rate and blood pressure were measured on day eight. Additionally, blood and saliva samples were taken from all the participants. Dietary records of seven days were also collected in order to confirm the foods and portion sizes consumed, preparation methods, recipes and any brand names.

Intervention Type OTHER

Chlorhexidine mouthwash

After using placebo and complete all the physiological measurements, participants were given a further one-week supply of antibacterial mouthwash containing 0.2% chlorhexidine (Corsodyl, GlaxoSmithKline, UK), encouraged to rinse their mouth for one minute, twice a day for 7 more days. They returned to the laboratory in 7 days to repeat all measurements in the same order.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy vegetarians (vegans and ovo-lacto vegetarians) following this dietary pattern for at least a year.
* Health omnivores

Exclusion Criteria

* Smokers
* Individuals taking any medications or recreational drugs.
* Individuals with pre-existing medical conditions such as hypertension, diabetes, dyslipidaemia or dental conditions (gingivitis).
* Individuals using mouthwash or tongue scrapes were excluded from this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the West of Scotland

OTHER

Sponsor Role collaborator

University of Plymouth

OTHER

Sponsor Role lead

Responsible Party

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Raul Bescos

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raul Bescos, PhD

Role: STUDY_DIRECTOR

University of Plymouth

Locations

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Laboratory of Nutrition, Exercise & Health

Plymouth, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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15/16-469

Identifier Type: -

Identifier Source: org_study_id

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