Effects of Nitrate-rich Beetroot Juice in Pregnant Women With High Blood Pressure
NCT05241327 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2022-02-15
Summary
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.
Conditions
- Preeclampsia
- Hypertension
- Endothelial Dysfunction
- Nitric Oxide
- Oxidative Stress
- Proteinuria
- Kidney Diseases
Interventions
- DIETARY_SUPPLEMENT
-
Beetroot Juice
Inorganic Nitrate
Sponsors & Collaborators
-
The Swedish Research Council
collaborator OTHER_GOV -
Swedish Heart Lung Foundation
collaborator OTHER - collaborator INDUSTRY
-
Danderyd Hospital
collaborator OTHER -
Karolinska University Hospital
collaborator OTHER - lead OTHER
Principal Investigators
-
Mattias Carlstrom, PharmD, PhD · Karolinska Institutet
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-01-01
- Primary Completion
- 2022-12-31
- Completion
- 2023-05-30
Countries
- Sweden
Study Locations
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