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

NCT05241327 | Unknown

• 1 other identifier: DNR-2020-01596
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypertension; Preeclampsia; Inorganic Nitrate; Endothelial dysfunction; Beetroot Juice

Outcome Measures

Primary Outcomes (2)

• Blood pressure (Office, Systolic)

  Reduction of office systolic pressure with 6%

  8-10 days supplementation with inorganic nitrate

• Blood pressure (Office, Diastolic)

  Reduction of office diastolic pressure with 6%

  8-10 days supplementation with inorganic nitrate

Secondary Outcomes (3)

• Blood Pressure (Mean Arterial Pressure, 24h ABPM)

  8-10 days supplementation with inorganic nitrate

• Endothelial function (Flow-mediated dilatation; FMD)

  8-10 days supplementation with inorganic nitrate

• Microvascular endothelium function (Laser Speckle Contrast Analysis; LASCA)

  8-10 days supplementation with inorganic nitrate

Study Arms (2)

Active

ACTIVE COMPARATOR

Beetroot Juice (Nitrate, 400 mg)

Dietary Supplement: Beetroot Juice

Placebo

PLACEBO COMPARATOR

Beetroot Juice (Nitrate, 0 mg)

Dietary Supplement: Beetroot Juice

Interventions

Beetroot Juice DIETARY_SUPPLEMENT

Inorganic Nitrate

Also known as: Beet It

Active; Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator
• Swedish Heart Lung Foundation: collaborator
• Novo Nordisk A/S: collaborator
• Danderyd Hospital: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Danderyd Hospital

Stockholm, SE-18257, Sweden

RECRUITING

Related Links

• Karolinska\_Institutet\_Mattias\_Carlstrom
• Karolinska\_Institutet\_Josefine\_Nasiell
• Karolinska\_Institutet\_Jonas\_Spaak
• Research\_Gate\_Mattias\_Carlstrom
• Research\_Gate\_Josefine\_Nasiell
• Research\_Gate\_Jonas\_Spaak

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension; Proteinuria; Kidney Diseases

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mattias Carlstrom, PharmD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Carlstrom, PharmD, PhD

CONTACT

+46-(0)-790680782; mattias.carlstrom@ki.se

Josefine Nasiell, MD, PhD

CONTACT

+46-(0)8-12357665; josefine.nasiell@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized placebo-controlled trial (RCT)

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 15, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: May 30, 2023
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)