Influence of Dietary Nitrate on Vascular Dysfunction and Inflammation

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

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2021-08-01

Brief Summary

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The principal research objective is to determine whether inorganic nitrate in the form of beetroot juice compared to placebo control prevents the systemic inflammation that underlies typhoid vaccine-induced endothelial dysfunction

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Detailed Description

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We wish to determine in a prospective manner whether inorganic nitrate affects the endothelial dysfunction induced by systemic inflammation. At baseline we will measure flow-mediated dilatation (FMD) and peripheral augmentation index, as well as aortic stiffness, as measured by pulse wave velocity (PWV). Volunteers will then receive \~8 mmols of dietary nitrate or nitrate free placebo juice once daily for 6 days. After this, depending on availability, volunteers will receive a typhoid vaccine Typherix®, GlaxoSmithKline UK or Typhim Vi ™, AAH Pharmaceuticals Ltd). This vaccine generates a mild systemic inflammation that is associated with vascular dysfunction. All vascular function measures will be repeated at 8 hours and 32 hours after vaccine administration.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nitrate-rich beetroot juice

Biological: Typhoid vaccine The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution Other Name: Typhim Vi®

Dietary Supplement: Concentrate beetroot Juice 140 ml containing \~8 mmol of inorganic nitrate

Group Type ACTIVE_COMPARATOR

Typhoid vaccine

Intervention Type BIOLOGICAL

The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution

Concentrate beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

140 ml containing \~8 mmol of inorganic nitrate

Nitrate-deplete beetroot juice

Biological: Typhoid vaccine The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution Other Name: Typhim Vi®

Dietary Supplement: Concentrate beetroot Juice 140 ml which is nitrate-depleted

Group Type PLACEBO_COMPARATOR

Typhoid vaccine

Intervention Type BIOLOGICAL

The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution

Concentrate beetroot Juice (Placebo)

Intervention Type DIETARY_SUPPLEMENT

140 ml which is nitrate-depleted

Interventions

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Typhoid vaccine

The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution

Intervention Type BIOLOGICAL

Concentrate beetroot Juice

140 ml containing \~8 mmol of inorganic nitrate

Intervention Type DIETARY_SUPPLEMENT

Concentrate beetroot Juice (Placebo)

140 ml which is nitrate-depleted

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Typhim Vi®

Eligibility Criteria

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Inclusion Criteria

1. Healthy volunteers
2. Aged 18-45
3. Volunteers who are willing to sign the consent form.
4. Normal resting blood pressure (\<140/90 mmHg)

Exclusion Criteria

1. Healthy subjects unwilling to consent
2. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result
3. History of any serious illnesses, including recent infections or trauma
4. Subjects taking systemic medication (other than the oral contraceptive pill)
5. Subjects with self-reported use of mouthwash or tongue scrapes
6. Subjects with recent (3 months) or current antibiotic use
7. Subjects with a history, or recent treatment of (within last 3 months) any oral condition (excluding caries), including gingivitis, periodontitis and halitosis
8. Subjects with a history of typhoid vaccination in the last 6 months
9. Subjects with any history of a blood-borne infectious disease such Hepatitis B or C virus, or HIV

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes