Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies

NCT06387784 | Not Yet Recruiting

• 1 other identifier: 2024/823
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Pre-Eclampsia; Pregnacy

Keywords

Pre-eclampsia; Pregnancy; Beetroot Juice; Nitric Oxide

Outcome Measures

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.

  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

  At 0, 3, and 6 hours after supplementation compared with a placebo group.

• Plasma Lipid Peroxidation Levels

  At 0, 3, and 6 hours after supplementation compared with a placebo group.

• Concentration of Total Antioxidant Capacity in Plasma

  At 0, 3, and 6 hours after supplementation compared with a placebo group.

• Maternal Blood Flow Velocity

  3 hours post-supplementation of beetroot juice or placebo.

• Fetal Heart Rate

  3 hours post-supplementation of beetroot juice or placebo.

Study Arms (4)

Early-onset pre-eclampsia beetroot juice

EXPERIMENTAL

A single dose of 70 ml of nitrate-rich beetroot juice containing 400 mg of nitrate.

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.

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.

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.

Dietary Supplement: Placebo juice

Interventions

Beetroot juice DIETARY_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.

Early-onset pre-eclampsia beetroot juice; Healthy pregnant woman beetroot juice.

Placebo juice DIETARY_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.

Early-onset pre-eclampsia placebo juice; Healthy pregnant woman placebo juice.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Healthy Pregnant Women
• 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.

Sponsors & Collaborators

• Hospital das Clínicas de Ribeirão Preto: collaborator
• Universidade Estadual Paulista Júlio de Mesquita Filho: collaborator
• University of Sao Paulo: lead

Study Sites (2)

Hospital das Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 35180074, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ricardo C Cavalli, Dr

  Medical School of Ribeirao Preto, USP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscila O Barbosa, Dr

CONTACT

+55166021000; barbosapo@usp.br

Sara T Caetano dos Santos, BSc

CONTACT

+5511971973623

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 29, 2024
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)