Gestational HypertensionNCT03930693
Role of the Oral Microbiome in Blood Pressure Regulation in Pregnancy
A study testing Beetroot juice in people with Gestational Hypertension, run by University of Manchester at 1 site in United Kingdom.
Trial summary
High blood pressure in pregnancy is associated with poor outcomes for both mum and baby, increasing the risk of pregnancy complications including pre-eclampsia, fetal growth restriction and preterm birth. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Hypertension
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2019to 31 Mar 2022
- Phase
- Interventional
- 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 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Normotensive or hypertensive women (hypertension as systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg OR on anti-hypertensive medication)
- For pregnant women, between 20-28 weeks gestation
Who cannot join
- Multi-fetal pregnancy (for pregnant women)
- Age under 16, or over 45 years of age
- Lacking ability to consent
- Pre-existing diabetes (Type 1/Type 2)
- Previous history of pre-term FGR (delivery before 32 weeks with FGR)
- Current tobacco smoker
Show all 11Show fewer
- Body Mass Index greater than or equal to 40 or less than or equal to 18
- Use of any of the following drugs in the last 6 months: systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral)
- Large doses of commercial probiotics (greater than or equal to 108 cfu or organisms per day) including tablets, capsules, lozenges, chewing gum or powders (ordinary dietary components such as yoghurts do not apply)
- Evidence of oral disease, assessed on screening proforma (current conditions of: oral candidiasis (thrush); Dental caries (tooth decay); Halitosis; Oral ulcerations/mouth ulcers; Wisdom tooth pain; Chronic dry mouth)
- Allergy to beetroot juice or lemon juice (both contained within the juice shot)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Maternal and Fetal Health Research Centre, St Mary's Hospital
Manchester
About this study
Official title: Investigation of the Oral Microbiome in Pregnancy - do Differences in Oral Bacterial Profiles and Nitrate Metabolism Contribute to Blood Pressure Regulation in Pregnant Women?
High blood pressure in pregnancy is associated with poor outcomes for both mum and baby, increasing the risk of pregnancy complications including pre-eclampsia, fetal growth restriction and preterm birth. The development of new blood pressure lowering interventions suitable for use in pregnancy is a key research priority.
Inorganic nitrate is a compound found in certain types of food, particularly green leafy vegetables and beetroot. Nitrate provides an important source of nitric oxide (NO), a molecule involved in keeping blood vessels healthy and regulating blood pressure. Supplementation with nitrate in the diet, using interventions such as beetroot juice, has been shown to reduce blood pressure and improve blood vessel function.
Read more
In order for dietary nitrate to have these beneficial effects, it needs to be converted in the body to nitrite, via bacteria that live in the mouth (oral bacteria). Differences in oral bacteria, and how they metabolise nitrate, are thought to influence blood pressure regulation and potentially response to dietary nitrate supplementation.
This study aims to understand (1) whether pregnant women with high blood pressure have a different composition of oral bacteria compared to healthy pregnant women and women who are not pregnant, and (2) how differences in oral bacteria affect blood pressure responses to a dose of dietary nitrate (in the form of beetroot juice).
- Conditions
- Gestational Hypertension
- Being tested
- Beetroot juice
- Keywords
- Pregnancy, hypertension, nitrate, beetroot juice
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
Beetroot juice shot (70mL containing 400mg inorganic nitrate)
| Study group | Role | What they receive |
|---|---|---|
| Normotensive pregnant women | Experimental | Normotensive pregnant women Receives: Dietary Supplement: Beetroot juice |
| Hypertensive pregnant women | Experimental | Hypertensive pregnant women Receives: Dietary Supplement: Beetroot juice |
| Normotensive non-pregnant women | Experimental | Normotensive non-pregnant women Receives: Dietary Supplement: Beetroot juice |
| Hypertensive non-pregnant women | Experimental | Hypertensive non-pregnant women Receives: Dietary Supplement: Beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of oral nitrate reducing bacterial species
Assessment of oral bacterial profile using next-generation sequencing (bacterial 16S rRNA sequencing)
Measured: Baseline
Oral bacterial nitrate reductase activity
Assessment of oral nitrate reductase activity, measured using enzyme assay
Measured: Baseline
Difference between groups in nitrate/nitrite concentrations before and after dietary nitrate dose
Measurement of plasma and salivary nitrate and nitrite concentrations, using high-performance liquid chromatography (HPLC)
Measured: Baseline to 2.5 hour post-nitrate dose
Secondary outcomes (1)
Difference between groups in blood pressure response to dietary nitrate dose
Change in blood pressure
Measured: Baseline to 2.5 hour post-nitrate dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start6 Jun 2019
- Primary completion12 Jul 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Beetroot juice intervention given to all participants (1 dose only)
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jenny Myers, University of Manchester
- Investigators
- Jenny Myers, BM, PhD, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930693
- Sponsor's protocol ID
- 246813
- Status last verified
- May 2024
- First submitted
- 23 Apr 2019
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Willmott T, Ormesher L, McBain AJ, Humphreys GJ, Myers JE, Singh G, Lundberg JO, Weitzberg E, Nihlen C, Cottrell EC. Altered Oral Nitrate Reduction and Bacterial Profiles in Hypertensive Women Predict Blood Pressure Lowering Following Acute Dietary Nitrate Supplementation. Hypertension. 2023 Nov;80(11):2397-2406. doi: 10.1161/HYPERTENSIONAHA.123.21263. Epub 2023 Sep 13.
PubMed 37702047
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Oral Microbiome in Pregnancy - do Differences in Oral Bacterial Profiles and Nitrate Metabolism Contribute to Blood Pressure Regulation in Pregnant Women?
- ClinicalTrials.gov ID
- NCT03930693
- Acronym / sponsor ID
- 246813
- Conditions
- Gestational Hypertension
- Keywords
- Pregnancy, hypertension, nitrate, beetroot juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High blood pressure in pregnancy is associated with poor outcomes for both mum and baby, increasing the risk of pregnancy complications including pre-eclampsia, fetal growth restriction and preterm birth. The development of new blood pressure lowering interventions suitable for use in pregnancy is a key research priority.
Inorganic nitrate is a compound found in certain types of food, particularly green leafy vegetables and beetroot. Nitrate provides an important source of nitric oxide (NO), a molecule involved in keeping blood vessels healthy and regulating blood pressure. Supplementation with nitrate in the diet, using interventions such as beetroot juice, has been shown to reduce blood pressure and improve blood vessel function.
In order for dietary nitrate to have these beneficial effects, it needs to be converted in the body to nitrite, via bacteria that live in the mouth (oral bacteria). Differences in oral bacteria, and how they metabolise nitrate, are thought to influence blood pressure regulation and potentially response to dietary nitrate supplementation.
This study aims to understand (1) whether pregnant women with high blood pressure have a different composition of oral bacteria compared to healthy pregnant women and women who are not pregnant, and (2) how differences in oral bacteria affect blood pressure responses to a dose of dietary nitrate (in the form of beetroot juice).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Beetroot juice intervention given to all participants (1 dose only)
| Arm | Type | Receives |
|---|---|---|
| Normotensive pregnant women | Experimental | Dietary Supplement: Beetroot juiceNormotensive pregnant women |
| Hypertensive pregnant women | Experimental | Dietary Supplement: Beetroot juiceHypertensive pregnant women |
| Normotensive non-pregnant women | Experimental | Dietary Supplement: Beetroot juiceNormotensive non-pregnant women |
| Hypertensive non-pregnant women | Experimental | Dietary Supplement: Beetroot juiceHypertensive non-pregnant women |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Normotensive or hypertensive women (hypertension as systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg OR on anti-hypertensive medication)
- For pregnant women, between 20-28 weeks gestation
Key exclusion criteria (11 listed)
- Multi-fetal pregnancy (for pregnant women)
- Age under 16, or over 45 years of age
- Lacking ability to consent
- Pre-existing diabetes (Type 1/Type 2)
- Previous history of pre-term FGR (delivery before 32 weeks with FGR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juiceBeetroot juice shot (70mL containing 400mg inorganic nitrate) | Dietary supplement | Hypertensive non-pregnant women, Hypertensive pregnant women, Normotensive non-pregnant women, Normotensive pregnant women |
Primary outcome
Quantity of oral nitrate reducing bacterial species
Time frame: Baseline
Assessment of oral bacterial profile using next-generation sequencing (bacterial 16S rRNA sequencing)
Oral bacterial nitrate reductase activity
Time frame: Baseline
Assessment of oral nitrate reductase activity, measured using enzyme assay
Difference between groups in nitrate/nitrite concentrations before and after dietary nitrate dose
Time frame: Baseline to 2.5 hour post-nitrate dose
Measurement of plasma and salivary nitrate and nitrite concentrations, using high-performance liquid chromatography (HPLC)
1 secondary outcome
Difference between groups in blood pressure response to dietary nitrate dose
Time frame: Baseline to 2.5 hour post-nitrate dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 37702047Willmott T, Ormesher L, McBain AJ, Humphreys GJ, Myers JE, Singh G, Lundberg JO, Weitzberg E, Nihlen C, Cottrell EC. Altered Oral Nitrate Reduction and Bacterial Profiles in Hypertensive Women Predict Blood Pressure Lowering Following Acute Dietary Nitrate Supplementation. Hypertension. 2023 Nov;80(11):2397-2406. doi: 10.1161/HYPERTENSIONAHA.123.21263. Epub 2023 Sep 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Myers, BM, PhD principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice in people with Gestational Hypertension, run by University of Manchester 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 2 inclusion and 11 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 16 May 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Quantity of oral nitrate reducing bacterial species (time frame: Baseline). The study lists 3 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 NCT03930693, which also lists 1 linked publication.
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 16 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.