- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03930693
Role of the Oral Microbiome in Blood Pressure Regulation in Pregnancy
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Elizabeth Cottrell, PhD
- Phone Number: +44 (0) 161 701 6957
- Email: elizabeth.cottrell@manchester.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normotensive pregnant women
|
Beetroot juice shot (70mL containing 400mg inorganic nitrate)
|
Experimental: Hypertensive pregnant women
|
Beetroot juice shot (70mL containing 400mg inorganic nitrate)
|
Experimental: Normotensive non-pregnant women
|
Beetroot juice shot (70mL containing 400mg inorganic nitrate)
|
Experimental: Hypertensive non-pregnant women
|
Beetroot juice shot (70mL containing 400mg inorganic nitrate)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantity of oral nitrate reducing bacterial species
Time Frame: Baseline
|
Assessment of oral bacterial profile using next-generation sequencing (bacterial 16S rRNA sequencing)
|
Baseline
|
Oral bacterial nitrate reductase activity
Time Frame: Baseline
|
Assessment of oral nitrate reductase activity, measured using enzyme assay
|
Baseline
|
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)
|
Baseline to 2.5 hour post-nitrate dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference between groups in blood pressure response to dietary nitrate dose
Time Frame: Baseline to 2.5 hour post-nitrate dose
|
Change in blood pressure
|
Baseline to 2.5 hour post-nitrate dose
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between salivary nitrate reductase activities and the change in salivary/plasma nitrite concentrations post-nitrate dose
Time Frame: Baseline to 2.5 hour post-nitrate dose
|
Change in nitrite vs. baseline nitrate reductase activity
|
Baseline to 2.5 hour post-nitrate dose
|
Correlation between changes in plasma nitrite concentrations and blood pressure lowering post-nitrate dose
Time Frame: Baseline to 2.5 hour post-nitrate dose
|
Change in plasma nitrite vs. change in blood pressure
|
Baseline to 2.5 hour post-nitrate dose
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jenny Myers, BM, PhD, Manchester University NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 246813
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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