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.
The study will include women diagnosed with early-onset preeclampsia and a healthy pregnancy, in accordance with the guidelines of the American College of Obstetricians and Gynecologists. Participants will be required to sign informed consent forms following a detailed explanation of the study. Four groups will be formed, with twenty-four pregnant women randomly assigned to each group using a free online program. In each group (early-onset preeclampsia), twenty-four pregnant women will receive nitrate-enriched beet juice (Beet It®, James White, UK), while another twenty-four pregnant women will receive an equivalent amount of placebo juice. Additionally, the same division applies to the group of healthy pregnant women, with six healthy pregnant women receiving the nitrate-enriched beet juice and six healthy pregnant women receiving the placebo. The study will begin in the morning, between 7:30 a.m. and 8:30 a.m., following a standardized, low-nitrate breakfast provided by the hospital. Participants will be instructed to avoid nitrate-rich foods the night before and will receive guidance from the project team and the hospital's nutrition service. The hospital's nutrition team will supervise dietary procedures. Ambulatory blood pressure monitoring will be performed at time -30 minutes (before juice or placebo intake), 0 hours, 3 hours, and 6 hours after juice or placebo intake. Saliva samples will be collected to assess nitrate reductase activity, and blood samples will be drawn to measure nitrate, nitrite, and nitrosothiol (nitric oxide metabolites), as well as to perform biochemical analyses of oxidative stress. Doppler ultrasound and Doppler velocimetry evaluation will be conducted at the peak action time of nitrate, which is estimated to occur three hours post-ingestion, based on previous research.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
In 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.
In 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.
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, Brazil
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.
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.
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.
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.
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.
Fetal Heart Rate
Fetal heart rate will be measured in beats per minute (bpm) using Doppler ultrasound, in each study group.
Time frame: 3 hours post-supplementation of beetroot juice or placebo.
Umbilical Arterial Pulsatility Index
The umbilical arterial pulsatility index will be calculated and reported as a percentile, in each group.
Time frame: 3 hours post-supplementation of beetroot juice or placebo.
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