Mode
Text Size
Log in / Sign up
N/A N=26 Randomized Triple-blind Treatment

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

Raynaud Phenomenon

Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Peripheral Blood Flow — 3.7; 3.7; 4.1; 3.7 flux.mmHg-1

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Concentrated beetroot juice (Dietary_supplement)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Portsmouth
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Peripheral Blood Flow
3.7; 3.7; 4.1; 3.7; 4.7; 5.2
PRIMARY
Skin Temperature.
32.4; 32.4; 32.1; 32.0; 32.2; 32.4
SECONDARY
Perceived Discomfort
13.4; 13.4; 13.1; 12.6; 13.5; 12.9
SECONDARY
Acceptability to Participants
10; 10
SECONDARY
Overall Number of Participants Recruited
23
SECONDARY
Perceived Pain
0.2; 0.2; 0.3; 0.2; 0.2; 0.9
SECONDARY
Feasible to Participants
10; 10
SECONDARY
Establish Retention Rates
23

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.

Eligibility Criteria

Inclusion Criteria

  • Male or Female, aged 18 years or above.
  • Diagnosed with Raynaud's Phenomenon.
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

  • Patients with significant renal impairment (eGFR<30)
  • Uncontrolled hypertension,
  • Taking regular organic nitrates, nicorandil, or thiazolidinidiones,
  • or any medication which may interfere with data interpretation or safety,
  • who have had a myocardial infarction or cerebro-vascular event,
  • who smoke,
  • or any other serious medical condition which would interfere with data interpretation or safety will be excluded from participation.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03129178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search