Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorUniversity of Sao Paulo
About this trial
Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy, characterized by high blood pressure and damage to organs such as the kidneys and liver. Currently, treatment options are limited, which has prompted researchers to explore alternative approaches. One such promising alternative is dietary nitrate found in vegetables like beetroot, as nitrate can be converted into nitric oxide in the body, which helps lower blood pressure. This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure, several blood and salivary markers in pregnant women with pre-eclampsia and healthy pregnant. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. We want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, we seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pre-eclampsia pregnat women
Pregnant women at or beyond the 20th week of gestation.
Hospitalized at Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto.
Diagnosed with early-onset pre-eclampsia confirmed by a medical professional.
Disqualifiers
Multiple pregnancies.
Uncontrolled arterial hypertension (Systolic Blood Pressure > 160 mmHg or Diastolic Blood Pressure > 100 mmHg).
Pregnant women with a body mass index > 40 kg/m²
Severe gestational complications.
Trial design
Design model
Parallel
Treatments tested in this trial
Beetroot juice
Dietary supplementIn the morning, pregnant women with pre-eclampsia will consume a single dose of 70 ml of nitrate-rich beetroot juice containing 400 mg of nitrate. Participants will be monitored to assess the acute effects of nitrate intake for 6 hours.
Placebo juice
Dietary supplementIn the morning, pregnant women with pre-eclampsia will consume 70 ml of a placebo juice. The placebo juice will be similar in appearance and taste to the nitrate-rich beetroot juice. Participants will be monitored to compare the acute effects of beetroot juice with the placebo intake for 6 hours.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Early-onset pre-eclampsia beetroot juiceExperimental treatment 1 intervention
Group B: Early-onset pre-eclampsia placebo juicePlacebo comparator 1 intervention
Group C: Healthy pregnant woman beetroot juice.Experimental treatment 1 intervention
Group D: Healthy pregnant woman placebo juice.Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Acute Effect of Beetroot Juice Supplementation on Blood Pressure
Evaluation of the acute effect of beetroot juice supplementation on blood pressure (measured in millimeters of mercury-mmHg) in pregnant women diagnosed with early preeclampsia and in healthy pregnant women.
Time frame
At 0, 3, and 6 hours after supplementation, beginning 30 minutes prior to ingestion, compared with a placebo group.Secondary outcomes
1
Plasma Concentrations of Nitric Oxide Metabolites
Assessment of plasma concentrations of nitric oxide metabolites (nitrite, nitrate and nitrosothiol) in pregnant women diagnosed with pre-eclampsia, comparing those receiving beetroot juice supplementation and those receiving placebo.
Time frame
At 0, 3, and 6 hours after supplementation compared with a placebo group.2
Plasma Lipid Peroxidation Levels
Assessment of the degree of lipid peroxidation, measured by the level of malondialdehyde in each study group.
Time frame
At 0, 3, and 6 hours after supplementation compared with a placebo group.3
Concentration of Total Antioxidant Capacity in Plasma
Determination of the plasma concentration of total antioxidant capacity of plasma, measured in Trolox equivalent antioxidant capacity, in each study group.
Time frame
At 0, 3, and 6 hours after supplementation compared with a placebo group.4
Maternal Blood Flow Velocity
Maternal blood flow velocity will be measured in centimeters per second (cm/s) using Doppler ultrasound, in each study group.
Time frame
3 hours post-supplementation of beetroot juice or placebo.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo
Lead sponsor
Hospital das Clínicas de Ribeirão Preto
Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborator
Source ClinicalTrials.gov
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