Pre-Eclampsia, Pregnacy
Conditions
Keywords
Pre-eclampsia, Pregnancy, Beetroot Juice, Nitric Oxide
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBeetroot juice
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.
DIETARY_SUPPLEMENTPlacebo juice
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.
Sponsors
University of Sao Paulo
Hospital das Clínicas de Ribeirão Preto
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized, placebo-controlled, single-blind, parallel-group study assessing acute rich-nitrate juice on pregnant women diagnosed with early pre-eclampsia and healthy pregnancy. Participants will be divided into four distinct groups: two groups of pregnant women diagnosed with early preeclampsia and two groups of healthy pregnant women. Within each group, participants will be further divided into a control group and a treatment group. Participants will be randomly assigned to these groups using an online program.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Pre-eclampsia pregnat women Inclusion Criteria: * 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. * Capacity to provide written informed consent for study participation.
Exclusion criteria
* 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. * History of food allergy with hypersensitivity to beetroot. * Smokers. * Chronic alcohol consumption. * Medications such as non-steroidal anti-inflammatory drugs, nasal decongestants, users of proton pump inhibitors and H2 receptor antagonists or any other medication that interferes with stomach pH. * Diagnosis of renal or hepatic disease affecting nitrate metabolism. * Cardiac conditions such as moderate to severe congestive heart failure and coronary artery disease. * Pre-existing type 1 or type 2 diabetes. 2. Healthy Pregnant Women Inclusion Criteria: * Healthy pregnant women at or beyond the 20th week of gestation. * Absence of pre-eclampsia diagnosis or other obstetric complications. * Willingness and ability to remain admitted at the Clinical Research Unit for the - period required by the study. * Capacity to provide written informed consent for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Effect of Beetroot Juice Supplementation on Blood Pressure | At 0, 3, and 6 hours after supplementation, beginning 30 minutes prior to ingestion, compared with a placebo group. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of Nitric Oxide Metabolites | At 0, 3, and 6 hours after supplementation compared with a placebo group. | 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. |
| Plasma Lipid Peroxidation Levels | At 0, 3, and 6 hours after supplementation compared with a placebo group. | Assessment of the degree of lipid peroxidation, measured by the level of malondialdehyde in each study group. |
| Concentration of Total Antioxidant Capacity in Plasma | At 0, 3, and 6 hours after supplementation compared with a placebo group. | Determination of the plasma concentration of total antioxidant capacity of plasma, measured in Trolox equivalent antioxidant capacity, in each study group. |
| Maternal Blood Flow Velocity | 3 hours post-supplementation of beetroot juice or placebo. | Maternal blood flow velocity will be measured in centimeters per second (cm/s) using Doppler ultrasound, in each study group. |
| Fetal Heart Rate | 3 hours post-supplementation of beetroot juice or placebo. | Fetal heart rate will be measured in beats per minute (bpm) using Doppler ultrasound, in each study group. |
| Umbilical Arterial Pulsatility Index | 3 hours post-supplementation of beetroot juice or placebo. | The umbilical arterial pulsatility index will be calculated and reported as a percentile, in each group. |
Countries
Brazil
Contacts
CONTACTPriscila O Barbosa, Dr
CONTACTSara T Caetano dos Santos, BSc
PRINCIPAL_INVESTIGATORRicardo C Cavalli, Dr
Medical School of Ribeirao Preto, USP
Outcome results
None listed