跳至主要内容
临床试验/NCT05241327
NCT05241327Unknown不适用

Effects of Nitrate-rich Beetroot Juice in Pregnant Women With High Blood Pressure

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Blood pressure (Office, Diastolic)

研究概览

简要总结

BACKGROUND: Preeclampsia (PE) is a serious syndrome that affects 3-7% of all pregnant women. PE is characterized by hypertension and kidney problems after the 20th week of pregnancy and is associated with an increased risk of serious cardiovascular complications including death in both mother and fetus. The underlying disease mechanisms are not clear, but that there are changes in the vessels and their function is generally accepted. Today, there is a lack of medical treatment in the form of medicines.

HYPOTHESIS: So-called oxidative stress and deficiency of the vasodilator nitric oxide (NO) play an important role in disease onset and complications in PE.

WORK PLAN: This interdisciplinary project combines clinical and experimental studies to investigate the significance of oxidative stress and NO deficiency in PE. We have shown in previous studies that nitrate, which is found in high levels in lettuce and beets, can be converted to NO in the body. In a feasibility study, blood samples were taken from women with PE and healthy pregnant women. Analysis of these samples has shown that women with PE and their newborns have lower levels of nitrate and markers of NO in the blood. In a clinical study, the physiological effects (cardiovascular function, renal function, metabolic function) of an increased daily nitrate intake (in the form of a specially developed beetroot juice) are examined in patients with PE. Blood and urine samples are collected before and after beetroot intervention and during childbirth when umbilical cord and placenta samples are also collected. The samples are analyzed with biochemical analyzes with regard to e.g. oxidative stress and NO.

IMPORTANCE: The project is expected to contribute new and important knowledge regarding the disease mechanisms, which may enable new treatment strategies in PE.

详细描述

OVERALL PURPOSE:

  1. Study the underlying disease mechanisms in preeclampsia Investigate the physiological effects of dietary nitrate in preeclampsia, in order to increase the production of nitric oxide in the body.

SPECIFIC GOALS:

Can increased intake of nitrate via the diet:

  • increase the availability and function of nitric oxide?
  • improve vascular function?
  • lower blood pressure?
  • reduce the morbidity of these patients and their newborns?

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double-Blind

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult and decision-making patient who:
  • is pregnant from week 20
  • has normal blood pressure (controls) or high blood pressure during the current pregnancy (either chronic hypertension, gestational hypertension or preeclampsia)
  • are cared for at Danderyd Hospital (Women's Clinic; Obstetrics and Gynecology)

排除标准

  • Type 1 diabetes
  • Vegetarians and vegans
  • Regular use/need for proton pump inhibitors (PPi)

结局指标

主要结局

Blood pressure (Office, Diastolic)

时间窗: 8-10 days supplementation with inorganic nitrate

Reduction of office diastolic pressure with 6%

Blood pressure (Office, Systolic)

时间窗: 8-10 days supplementation with inorganic nitrate

Reduction of office systolic pressure with 6%

次要结局

  • Microvascular endothelium function (Laser Speckle Contrast Analysis; LASCA)(8-10 days supplementation with inorganic nitrate)
  • Endothelial function (Flow-mediated dilatation; FMD)(8-10 days supplementation with inorganic nitrate)
  • Blood Pressure (Mean Arterial Pressure, 24h ABPM)(8-10 days supplementation with inorganic nitrate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mattias Carlström

Associate Professor

Karolinska Institutet

研究点 (2)

Loading locations...

相似试验