BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension (BEET-PAH)

March 24, 2018 updated by: Uppsala University
The study is a single center randomised, double-blind, placebo-controlled crossover study to assess the effects of beetroot juice in patients with pulmonary arterial hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PAH (pulmonary arterial hypertension)
  • WHO functional class II-III

Exclusion Criteria:

  • WHO functional class I or IV
  • pregnancy
  • known intolerance or allergy to beetroot
  • treatment with Allopurinol
  • treatment with Iloprost (inhaled)
  • systolic bloodpressure < 95 mmHg
  • diabetes mellitus type 2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitrate rich beetroot juice
Eligible subjects will be randomised, in a double-blind crossover design, to receive treatment with either nitrate rich beetroot juice (70 ml containing approximately 8 mmol nitrate - active comparator) or nitrate depleted beetroot juice (70 ml - placebo) twice daily for 7 days (treatment period 1) followed by a 7 day washout period followed by treatment twice daily with the active comparator or placebo depending on initial treatment for another 7 days (treatment period 2) .
Dietary supplement: Beetroot juice
Placebo Comparator: Nitrate depleted beetroot juice
Eligible subjects will be randomised, in a double-blind crossover design, to receive treatment with either nitrate rich beetroot juice (70 ml containing approximately 8 mmol nitrate - active comparator) or nitrate depleted beetroot juice (70 ml - placebo)twice daily for 7 days (treatment period 1) followed by a 7 day washout period followed by treatment twice daily with the active comparator or placebo depending on initial treatment for another 7 days (treatment period 2) .
Dietary supplement: Beetroot juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in VO2 submax and or VO2 max
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6MWT
Time Frame: 7 days
7 days
Change in WHO functional class
Time Frame: 7 days
7 days
Change in echocardiographic parameters
Time Frame: 7 days
Change in; pulmonary artery systolic pressure (PASP), ventricular diastolic function, systolic right and left ventricular function, right and left atrial/ventricular dimensions will be calculated
7 days
Change in exhaled NO
Time Frame: 7 days
7 days
Change in systemic bloodpressure
Time Frame: 7 days
7 days
Change in metabolic pathways involved in nitric oxide production and regulation
Time Frame: 7 days
Change in the following biochemical variables will be calculated; ADMA, SDMA, Arginine, Citrulline, Ornithine, uric acid, nitrate, nitrite
7 days
Change in NT-pro-BNP
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Gerhard Wikström, MD, PhD, Uppsala University and Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 24, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEET-PAH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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