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

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Beetroot Juice

Inorganic Nitrate

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV
  • Swedish Heart Lung Foundation

    collaborator OTHER
  • Novo Nordisk A/S

    collaborator INDUSTRY
  • Danderyd Hospital

    collaborator OTHER
  • Karolinska University Hospital

    collaborator OTHER
  • Karolinska Institutet

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05241327 on ClinicalTrials.gov