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Beet the Cold: The Effect of Inorganic Nitrate Supplementation in Individuals With Raynaud's Phenomenon

NCT03129178 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-02-10

Study results available
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Summary

Individuals with Raynaud's phenomenon often experience episodes of reduced blood flow to their fingers and toes during times of stress or cold exposure, causing significant discomfort and pain. Typically, treatment for these individuals involves using drugs like Glyceryl Trinitrate (GTN), which increases blood flow to the fingers and toes by increasing a substance called nitric oxide in the blood. Unfortunately, repeated use of these drugs increases tolerance to them, meaning higher doses are required to produce the same effect. However, increasing the dose can cause more side effects like headaches, and is therefore not considered an ideal long-term therapy.

Leafy green vegetables, especially beetroot, contain high amounts of nitrate and are beneficial to blood vessel health, since nitrate from the diet can also be turned into the important blood vessel relaxer, nitric oxide. Unlike GTN, people don't appear to develop a tolerance to dietary nitrate or experience negative side effects.

Therefore, this study aims to see if short and longer term beetroot juice supplementation can improve blood flow to the hands and feet in individuals with Raynaud's phenomenon, as well as reduce their pain. This study will tell us how many people are needed for a definitive trial investigating whether beetroot juice can help treat Raynaud's phenomenon.

Raynaud's phenomenon can cause significant discomfort and pain to individuals. Dietary nitrate appears to offer a simple, low cost means of improving blood flow to the hands and feet which should reduce both the discomfort and pain experienced characterising this condition. This study will advance our understanding of the causes of Raynaud's phenomenon, specifically the role that the nitrate-nitrite-nitric oxide pathway might play in changing Raynaud's phenomenon symptoms and identifying targets for intervention.

Conditions

  • Raynaud Phenomenon

Interventions

DIETARY_SUPPLEMENT

Concentrated beetroot juice

Acute and chronic supplementation of beetroot juice.

Sponsors & Collaborators

  • Loughborough University

    collaborator OTHER

  • University of Exeter

    collaborator OTHER

  • University of Portsmouth

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-07-01
Completion
2018-10-01

Countries

  • United Kingdom

Study Locations

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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 NCT03129178 on ClinicalTrials.gov