An interventional study of Beetroot juice in Gestational Hypertension, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to female participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University of Manchester · Not applicable, Interventional, and Basic science
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).
245 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 68 are open to participants now.
This study's enrollment of 55 is below the median of 142 across 166 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →University of Manchester is the lead sponsor of 201 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Normotensive pregnant women
Dietary Supplement: Beetroot juice
Hypertensive pregnant women
Dietary Supplement: Beetroot juice
Normotensive non-pregnant women
Dietary Supplement: Beetroot juice
Hypertensive non-pregnant women
Dietary Supplement: Beetroot juice
Beetroot juice shot (70mL containing 400mg inorganic nitrate)
Quantity of oral nitrate reducing bacterial species
Assessment of oral bacterial profile using next-generation sequencing (bacterial 16S rRNA sequencing)
Time frame: Baseline
Oral bacterial nitrate reductase activity
Assessment of oral nitrate reductase activity, measured using enzyme assay
Time frame: 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)
Time frame: Baseline to 2.5 hour post-nitrate dose
Difference between groups in blood pressure response to dietary nitrate dose
Change in blood pressure
Time frame: Baseline to 2.5 hour post-nitrate dose
Correlation between salivary nitrate reductase activities and the change in salivary/plasma nitrite concentrations post-nitrate dose
Change in nitrite vs. baseline nitrate reductase activity
Time frame: Baseline to 2.5 hour post-nitrate dose
Correlation between changes in plasma nitrite concentrations and blood pressure lowering post-nitrate dose
Change in plasma nitrite vs. change in blood pressure
Time frame: Baseline to 2.5 hour post-nitrate dose
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beet juice
Hypertension, Pregnancy-Induced →