Pre-EclampsiaBEET_PENCT06387784
Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies
A study testing Beetroot juice in people with Pre-Eclampsia and Pregnacy, run by University of Sao Paulo at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pre-Eclampsia, Pregnacy
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- 18 May 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
- Healthy Pregnant Women
- The same exclusion criteria from Pre-eclampsia group apply.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sara T Caetano dos Santos, BSc contact
Brazil2 sites
Hospital das Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, 35180074
Priscila Barbosa, Dr, +55163602-2800, barbosapo@usp.br
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo
About this study
Official title: Acute Effect of Beetroot Juice Supplementation in Pregnant Women With Pre-eclampsia: a Single-Blind Randomized Placebo-Controlled 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.
Read the 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.
- Conditions
- Pre-Eclampsia, Pregnacy
- Being tested
- Beetroot juice, Placebo juice
- Keywords
- Pre-eclampsia, Pregnancy, Beetroot Juice, Nitric Oxide
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
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.
Placebo juiceDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Early-onset pre-eclampsia beetroot juice | Experimental | A single dose of 70 ml of nitrate-rich beetroot juice containing 400 mg of nitrate. Receives: Dietary Supplement: Beetroot juice |
| Early-onset pre-eclampsia placebo juice | Placebo comparator | A single dose of 70 ml of a formulation with a similar taste, smell, and texture. Receives: Dietary Supplement: Placebo juice |
| Healthy pregnant woman beetroot juice. | Experimental | A single dose of 70 ml of nitrate-rich beetroot juice containing 400 mg of nitrate. Receives: Dietary Supplement: Beetroot juice |
| Healthy pregnant woman placebo juice. | Placebo comparator | A single dose of 70 ml of a formulation with a similar taste, smell, and texture. Receives: Dietary Supplement: Placebo juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 0, 3, and 6 hours after supplementation, beginning 30 minutes prior to ingestion, compared with a placebo group.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 hours post-supplementation of beetroot juice or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start18 May 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto, Universidade Estadual Paulista Júlio de Mesquita Filho
- Responsible party
- Principal investigator, Ricardo de Carvalho Cavalli, University of Sao Paulo
- Investigators
- Ricardo C Cavalli, Dr, Principal investigator, Medical School of Ribeirao Preto, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387784
- Sponsor's protocol ID
- 2024/823
- Acronym
- BEET_PE
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will provide access to individual de-identified participant data and related study documents upon request from qualified researchers, subject to certain criteria, conditions, and exceptions.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Beetroot Juice Supplementation in Pregnant Women With Pre-eclampsia: a Single-Blind Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT06387784
- Acronym / sponsor ID
- BEET_PE / 2024/823
- Conditions
- Pre-Eclampsia, Pregnacy
- Keywords
- Pre-eclampsia, Pregnancy, Beetroot Juice, Nitric Oxide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto, Universidade Estadual Paulista Júlio de Mesquita Filho
- Study start
- 18 May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early-onset pre-eclampsia beetroot juice | Experimental | Dietary Supplement: Beetroot juiceA single dose of 70 ml of nitrate-rich beetroot juice containing 400 mg of nitrate. |
| Early-onset pre-eclampsia placebo juice | Placebo comparator | Dietary Supplement: Placebo juiceA single dose of 70 ml of a formulation with a similar taste, smell, and texture. |
| Healthy pregnant woman beetroot juice. | Experimental | Dietary Supplement: Beetroot juiceA single dose of 70 ml of nitrate-rich beetroot juice containing 400 mg of nitrate. |
| Healthy pregnant woman placebo juice. | Placebo comparator | Dietary Supplement: Placebo juiceA single dose of 70 ml of a formulation with a similar taste, smell, and texture. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- Healthy Pregnant Women
- The same exclusion criteria from Pre-eclampsia group apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juiceIn 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 supplement | Early-onset pre-eclampsia beetroot juice, Healthy pregnant woman beetroot juice. |
| Placebo juiceIn 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. | Dietary supplement | Early-onset pre-eclampsia placebo juice, Healthy pregnant woman placebo juice. |
Primary outcome
Acute Effect of Beetroot Juice Supplementation on Blood Pressure
Time frame: 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.
6 secondary outcomes
Plasma Concentrations of Nitric Oxide Metabolites
Time frame: At 0, 3, and 6 hours after supplementation compared with a placebo group.
Plasma Lipid Peroxidation Levels
Time frame: At 0, 3, and 6 hours after supplementation compared with a placebo group.
Concentration of Total Antioxidant Capacity in Plasma
Time frame: At 0, 3, and 6 hours after supplementation compared with a placebo group.
Maternal Blood Flow Velocity
Time frame: 3 hours post-supplementation of beetroot juice or placebo.
Fetal Heart Rate
Time frame: 3 hours post-supplementation of beetroot juice or placebo.
Umbilical Arterial Pulsatility Index
Time frame: 3 hours post-supplementation of beetroot juice or placebo.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. We will provide access to individual de-identified participant data and related study documents upon request from qualified researchers, subject to certain criteria, conditions, and exceptions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara T Caetano dos Santos, BSc contact
Ricardo C Cavalli, Dr principal investigator
Medical School of Ribeirao Preto, USP
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice in people with Pre-Eclampsia and Pregnacy, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Priscila O Barbosa, Dr (+55166021000, barbosapo@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Effect of Beetroot Juice Supplementation on Blood Pressure (time frame: At 0, 3, and 6 hours after supplementation, beginning 30 minutes prior to ingestion, compared with a placebo group.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.