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AzTrials

Cardiovascular DiseasesPhase 1NCT02715635

Influence of Dietary Nitrate on Vascular Dysfunction and Inflammation

A Phase 1 study testing Typhoid vaccine and Concentrate beetroot Juice in people with Cardiovascular Diseases, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Typhoid vaccine and Concentrate beetroot Juice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2016to 1 Aug 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • William Harvey Research Institute, Barts and The London School of Medicine

    London, EC1M 6BQ

Other trials in United Kingdom

About this study

Official title: A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Effect of Dietary Nitrate on a Model of Vascular Dysfunction in Healthy Volunteers

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

Read the detailed description

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.

Being tested
Typhoid vaccine, Concentrate beetroot Juice, Concentrate beetroot Juice (Placebo)
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Typhoid vaccineBiological

    Also called Typhim Vi®

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

  • Concentrate beetroot JuiceDietary supplement

    140 ml containing ~8 mmol of inorganic nitrate

  • Concentrate beetroot Juice (Placebo)Dietary supplement

    140 ml which is nitrate-depleted

Study groups in NCT02715635
Study groupRoleWhat they receive
Nitrate-rich beetroot juiceActive comparatorBiological: 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
Receives: Biological: Typhoid vaccine; Dietary Supplement: Concentrate beetroot Juice
Nitrate-deplete beetroot juicePlacebo comparatorBiological: 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
Receives: Biological: Typhoid vaccine; Dietary Supplement: Concentrate beetroot Juice (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flow mediated dilatation

    Comparison of change in FMD from baseline after typhoid vaccination following inorganic nitrate versus placebo supplementation

    Measured: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)

  2. Plasma nitrite concentration

    Comparison of change in plasma nitrite concentration following inorganic nitrate versus placebo supplementation

    Measured: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)

Secondary outcomes (4)

  1. Markers of acute inflammation

    Comparison of change in peripheral markers of inflammation and leucocyte count following nitrate versus placebo supplementation

    Measured: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)

  2. Pulse wave velocity

    Comparison of change in PWV from baseline after typhoid vaccination following nitrate versus placebo supplementation

    Measured: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)

  3. Platelet reactivity

    Comparison of change in platelet reactivity from baseline after typhoid vaccination following nitrate versus placebo supplementation

    Measured: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)

  4. Plasma nitrate concentration

    Comparison of change in plasma nitrate concentration following inorganic nitrate versus placebo supplementation

    Measured: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2020
  4. Study completion1 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715635
Sponsor's protocol ID
15/LO/0789
Status last verified
Jul 2022
First submitted
16 Mar 2016
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
No

Publications

  • Hingorani AD, Cross J, Kharbanda RK, Mullen MJ, Bhagat K, Taylor M, Donald AE, Palacios M, Griffin GE, Deanfield JE, MacAllister RJ, Vallance P. Acute systemic inflammation impairs endothelium-dependent dilatation in humans. Circulation. 2000 Aug 29;102(9):994-9. doi: 10.1161/01.cir.102.9.994.

    PubMed 10961963

  • Kharbanda RK, Walton B, Allen M, Klein N, Hingorani AD, MacAllister RJ, Vallance P. Prevention of inflammation-induced endothelial dysfunction: a novel vasculo-protective action of aspirin. Circulation. 2002 Jun 4;105(22):2600-4. doi: 10.1161/01.cir.0000017863.52347.6c.

    PubMed 12045164

  • Donald AE, Charakida M, Cole TJ, Friberg P, Chowienczyk PJ, Millasseau SC, Deanfield JE, Halcox JP. Non-invasive assessment of endothelial function: which technique? J Am Coll Cardiol. 2006 Nov 7;48(9):1846-50. doi: 10.1016/j.jacc.2006.07.039. Epub 2006 Oct 17.

    PubMed 17084260

  • Clapp BR, Hingorani AD, Kharbanda RK, Mohamed-Ali V, Stephens JW, Vallance P, MacAllister RJ. Inflammation-induced endothelial dysfunction involves reduced nitric oxide bioavailability and increased oxidant stress. Cardiovasc Res. 2004 Oct 1;64(1):172-8. doi: 10.1016/j.cardiores.2004.06.020.

    PubMed 15364625

  • Lau C, Primus CP, Shabbir A, Chhetri I, Ono M, Masucci M, Bin Noorany Aubdool MA, Amarin J, Hamers AJ, Khan Z, Kumar NA, Montalvo Moreira SA, Nuredini G, Osman M, Whitear C, Godec T, Kapil V, Massimo G, Khambata RS, Rathod KS, Ahluwalia A. Accelerating inflammatory resolution in humans to improve endothelial function and vascular health: Targeting the non-canonical pathway for NO. Redox Biol. 2025 May;82:103592. doi: 10.1016/j.redox.2025.103592. Epub 2025 Mar 28.

    PubMed 40209616

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Typhoid vaccine and Concentrate beetroot Juice in people with Cardiovascular Diseases, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flow mediated dilatation (time frame: Day 1, Day 7 (8 hours post typhoid vaccine), Day 8 (32 hours post typhoid vaccine)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715635, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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