Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies

NCT ID: NCT06387784

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-06-30

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. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. The investigators want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, the investigators seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia.

Detailed Description

The study will include women diagnosed with either early-onset pre-eclampsia or late-onset pre-eclampsia, following the guidelines of the American College of Obstetricians and Gynecologists. Participants will be required to sign informed consent forms following a thorough explanation of the study. A total of four groups will be established, with twenty-four pregnant women randomly assigned to each group using a free online program. In each group (early-onset and late-onset pre-eclampsia), forty-eight pregnant women will receive nitrate-enriched beetroot juice (Beet It®, James White, UK), while another forty-eight will receive an equivalent amount of placebo juice. The trial will commence in the morning, between 7:30 and 8:30 am, after a standardized, low-nitrate breakfast provided by the hospital. Participants will be instructed to avoid nitrate-rich foods the previous evening and will receive guidance from the project team and the hospital's nutrition service. The hospital's nutritional team will oversee the dietary procedures. Ambulatory blood pressure monitoring will be conducted for six hours following the ingestion of juice or placebo. 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 two hours post-ingestion, based on previous research.

Conditions

Pre-Eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early-onset pre-eclampsia beetroot juice

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

Group Type: EXPERIMENTAL

Beetroot juice

Intervention Type: 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 placebo juice

A single dose of 70 ml of a formulation with a similar taste, smell, and texture.

Group Type: PLACEBO_COMPARATOR

Placebo juice

Intervention Type: 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.

Late-onset pre-eclampsia beetroot juice

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

Group Type: EXPERIMENTAL

Beetroot juice

Intervention Type: 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.

Late-onset pre-eclampsia placebo juice

A single dose of 70 ml of a formulation with a similar taste, smell, and texture.

Group Type: PLACEBO_COMPARATOR

Placebo juice

Intervention Type: 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.

Interventions

Beetroot 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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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 or late-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.
• Use of medications, except for antihypertensive.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital das Clínicas de Ribeirão Preto

OTHER

Sponsor Role: collaborator

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ricardo de Carvalho Cavalli

Professor Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo C Cavalli, Dr

Role: PRINCIPAL_INVESTIGATOR

Medical School of Ribeirao Preto, USP

Locations

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

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2024/823

Identifier Type: -

Identifier Source: org_study_id