Clinical Trials Directory

Trials / Completed

CompletedNCT03930693

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?

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
University of Manchester · Academic / Other
Sex
Female
Age
16 Years – 45 Years
Healthy volunteers
Accepted

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. 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).

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTBeetroot juiceBeetroot juice shot (70mL containing 400mg inorganic nitrate)

Timeline

Start date
2019-06-06
Primary completion
2021-07-12
Completion
2022-03-31
First posted
2019-04-29
Last updated
2024-05-16

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03930693. Inclusion in this directory is not an endorsement.