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

NCT03129178 | Completed Results DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nitrate; Nitric oxide; Microvascular

Outcome Measures

Primary Outcomes (2)

• Peripheral Blood Flow

  Peripheral blood flow (CVC = skin flux/MAP; flux.mmHg-1).

  Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).

• Skin Temperature.

  Skin temperature (via thermal imaging).

  Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).

Secondary Outcomes (6)

• Perceived Discomfort

  Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).

• Acceptability to Participants

  During qualitative interviews after the intervention has ended (post day 36).

• Overall Number of Participants Recruited

  From start of study recruitment until the last participant is randomised. Estimated assesment period 6 - 52 weeks

• Perceived Pain

  Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).

• Feasible to Participants

  During qualitative interviews after the intervention has ended (post day 36).

Study Arms (2)

Beetroot juice then nitrate depleted beetroot juice

EXPERIMENTAL

Participants will be asked to consume 140ml of beetroot juice prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.

Dietary Supplement: Concentrated beetroot juice

Nitrate depleted beetroot juice then beetroot juice

EXPERIMENTAL

Participants will be asked to consume 140ml of placebo prior to their first experimental visit. Participants will then be asked to consume 70ml a day for 2 weeks and final visit the investigators once more following another 140ml drink.

Dietary Supplement: Concentrated beetroot juice

Interventions

Concentrated beetroot juice DIETARY_SUPPLEMENT

Acute and chronic supplementation of beetroot juice.

Beetroot juice then nitrate depleted beetroot juice; Nitrate depleted beetroot juice then beetroot juice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Portsmouth: lead
• Loughborough University: collaborator
• University of Exeter: collaborator

Study Sites (1)

Department of Sport and Exercise Science

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Raynaud Disease

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr Anthony Shepherd
• Organization: University of Portsmouth

ant.shepherd@port.ac.uk

02392 84

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind, randomised control trial. Supplements will be dispensed by nurses or a member of the research team.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 26, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)