Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies

Pre-Eclampsia Clinical Trial

— BEET_PE  

Official title:

Acute Effect of Beetroot Juice Supplementation in Pregnant Women With Pre-eclampsia: a Single-Blind Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06387784
• Other study ID #: 2024/823
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Sao Paulo
• Contact: Priscila O Barbosa, Dr
• Phone: +55166021000
• Email: barbosapo[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Hospital das Clínicas de Ribeirão Preto, Universidade Estadual Paulista Júlio de Mesquita Filho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Effect of Beetroot Juice Supplementation on Blood Pressure	Assessment of the acute effect of beetroot juice supplementation on blood pressure (measured in millimetres of mercury - mmHg) in pregnant women diagnosed with early and late-onset pre-eclampsia, measured every 30 minutes up to 6 hours post-supplementation, starting 30 minutes before ingestion, compared to a placebo group.	Every 30 minutes up to 6 hours post-supplementation.
Secondary	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.	At baseline and up to 6 hours post-supplementation.
Secondary	Concentration of Salivary Nitrate Reductase Enzyme	Assessment of the activity of the nitrate reductase enzyme in saliva in each study group.	At baseline and up to 6 hours post-supplementation.
Secondary	Plasma Lipid Peroxidation Levels	Assessment of the degree of lipid peroxidation, measured by the level of malondialdehyde in each study group.	At baseline and up to 6 hours post-supplementation.
Secondary	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.	At baseline and up to 6 hours post-supplementation.
Secondary	Maternal Blood Flow Velocity	Maternal blood flow velocity will be measured in centimeters per second (cm/s) using Doppler ultrasound, in each study group.	2 hours post-supplementation of beetroot juice or placebo.
Secondary	Fetal Heart Rate	Fetal heart rate will be measured in beats per minute (bpm) using Doppler ultrasound, in each study group.	2 hours post-supplementation of beetroot juice or placebo.
Secondary	Umbilical Arterial Pulsatility Index	The umbilical arterial pulsatility index will be calculated and reported as a percentile, in each group.	2 hours post-supplementation of beetroot juice or placebo.