Acute Effect of Beetroot Juice Supplementation in Pregnant Women With Pre-eclampsia: a Single-Blind Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acute Effect of Beetroot Juice Supplementation on Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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
- •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.
- •Exclusion Criteria:
- •- The same exclusion criteria from Pre-eclampsia group apply.
研究组 & 干预措施
Early-onset pre-eclampsia beetroot juice
A single dose of 70 ml of nitrate-rich beetroot juice containing 400 mg of nitrate.
干预措施: Beetroot juice (Dietary Supplement)
Early-onset pre-eclampsia placebo juice
A single dose of 70 ml of a formulation with a similar taste, smell, and texture.
干预措施: Placebo juice (Dietary Supplement)
Healthy pregnant woman beetroot juice.
A single dose of 70 ml of nitrate-rich beetroot juice containing 400 mg of nitrate.
干预措施: Beetroot juice (Dietary Supplement)
Healthy pregnant woman placebo juice.
A single dose of 70 ml of a formulation with a similar taste, smell, and texture.
干预措施: Placebo juice (Dietary Supplement)
结局指标
主要结局
Acute Effect of Beetroot Juice Supplementation on Blood Pressure
时间窗: Every 30 minutes up to 6 hours post-supplementation.
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.
Acute Effect of Beetroot Juice Supplementation on Blood Pressure
时间窗: 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.
次要结局
- Concentration of Salivary Nitrate Reductase Enzyme(At baseline and up to 6 hours post-supplementation.)
- Maternal Blood Flow Velocity(2 hours post-supplementation of beetroot juice or placebo.)
- Concentration of Total Antioxidant Capacity in Plasma(At baseline and up to 6 hours post-supplementation.)
- Fetal Heart Rate(2 hours post-supplementation of beetroot juice or placebo.)
- Umbilical Arterial Pulsatility Index(2 hours post-supplementation of beetroot juice or placebo.)
- Plasma Concentrations of Nitric Oxide Metabolites(At baseline and up to 6 hours post-supplementation.)
- Plasma Lipid Peroxidation Levels(At baseline and up to 6 hours post-supplementation.)
- 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.)
- Umbilical Arterial Pulsatility Index(3 hours post-supplementation of beetroot juice or placebo.)
研究者
Ricardo de Carvalho Cavalli
Professor Dr
University of Sao Paulo