Primary Raynaud Phenomenon Clinical Trial
Official title:
Pilot Study to Investigate the Effect of Cocoa Flavanols on Symptoms in Primary Raynaud's Phenomenon
NCT number | NCT03815162 |
Other study ID # | 112-1809 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 16, 2018 |
Est. completion date | July 31, 2021 |
Verified date | November 2021 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to investigate the effect that supplementing the diet with cocoa flavanols has on vasospasm symptoms and temperature regulation in women with primary Raynaud's phenomenon (PRP). Participants will be randomised to consume either high flavanol cocoa extract or low flavanol cocoa (placebo) daily for 3 months.
Status | Completed |
Enrollment | 27 |
Est. completion date | July 31, 2021 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Experience symptoms of Primary Raynaud's Phenomenon, with >1 attack / week through the winter months - Daily consumption of caffeine containing foods/drinks. - BMI <27kg/m2 Exclusion Criteria: - pregnant or breast feeding (women only), - clinically significant metabolic or endocrine abnormalities - fasting glucose >6.5mmol/l, - taking Bosentan, aspirin, dipyridamole, heparin or transdermal nitrates, - herbal supplement use, - food allergies related to the investigational product (cocoa, peanuts, milk), - sensitivity to methylxanthines (e.g. caffeine, theobromine). - Presence or history of digital ulceration, - blood parameters suggesting secondary Raynaud's, - history of migraines |
Country | Name | City | State |
---|---|---|---|
United Kingdom | David Greenfield Human Physiology Laboratories | Nottingham | Notts |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Chung L, Shapiro L, Fiorentino D, Baron M, Shanahan J, Sule S, Hsu V, Rothfield N, Steen V, Martin RW, Smith E, Mayes M, Simms R, Pope J, Kahaleh B, Csuka ME, Gruber B, Collier D, Sweiss N, Gilbert A, Dechow FJ, Gregory J, Wigley FM. MQX-503, a novel formulation of nitroglycerin, improves the severity of Raynaud's phenomenon: a randomized, controlled trial. Arthritis Rheum. 2009 Mar;60(3):870-7. doi: 10.1002/art.24351. — View Citation
Herrick A. Raynaud's phenomenon. Curr Treat Options Cardiovasc Med. 2008 Apr;10(2):146-55. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vasospasm | frequency of vasospasm | 3 months | |
Secondary | Severity of vasospasm symptoms | visual analogue score for pain associated with each vasospasm occasion. Participants indicate pain intensity by placing a vertical line on a 100mm horizontal line where the start of the line (left-hand side; 0mm) represents 'no pain' and the end of the line (right-hand side; 100mm) represents 'most severe pain'. Distance of the vertical line from 0 provides the visual analogue score. A lower score indicates a more favourable outcome. | 3 months | |
Secondary | Duration of vasospasm symptoms | duration that symptoms persist for on each vasospasm occasion | 3 months | |
Secondary | Raynaud's Condition score | Assessment of Raynaud's symptoms using the validated Raynaud's Condition Score. This is a 1 to 10 Likert scale, with 0 representing 'no difficulty' and 10 indicating 'extreme difficulty' with symptoms; collected daily for 3 months, a lower score indicates a more favourable outcome. | 3 months | |
Secondary | Blood pressure | blood pressure measured by automated oscillometric blood pressure | pre-intervention | |
Secondary | Blood pressure | blood pressure measured by automated oscillometric blood pressure | 4 weeks after starting intervention | |
Secondary | Blood pressure | blood pressure measured by automated oscillometric blood pressure | 8 weeks after starting intervention | |
Secondary | Blood pressure | blood pressure measured by automated oscillometric blood pressure | 12 weeks after starting the intervention | |
Secondary | Dietary polyphenol intake | estimation of dietary polyphenols made by food frequency questionnaire | pre-intervention | |
Secondary | Dietary polyphenol intake | estimation of dietary polyphenols made by food frequency questionnaire | 4 weeks after starting intervention | |
Secondary | Dietary polyphenol intake | estimation of dietary polyphenols made by food frequency questionnaire | 8 weeks after starting intervention | |
Secondary | Dietary polyphenol intake | estimation of dietary polyphenols made by food frequency questionnaire | 12 weeks after starting the intervention | |
Secondary | Ambient skin temperature | skin temperature of a finger exposed to an environmental temperature of 25oC, before cooling | pre-intervention | |
Secondary | Ambient skin temperature | skin temperature of a finger exposed to an environmental temperature of 25oC, before cooling | 12 weeks after starting the intervention | |
Secondary | Ambient skin blood flow | finger blood flow (measured using laser Doppler flowmetry) when exposed to an environmental temperature of 25oC, before cooling | pre-intervention | |
Secondary | Ambient skin blood flow | finger blood flow (measured using laser Doppler flowmetry) when exposed to an environmental temperature of 25oC, before cooling | 12 weeks after starting the intervention | |
Secondary | Skin temperature response to acute cooling | The time taken for skin temperature of the finger to stabilise in response to localised cooling (in an air temperature of 0oC) | pre-intervention | |
Secondary | Skin temperature response to acute cooling | The time taken for skin temperature of the finger to stabilise in response to localised cooling (in an air temperature of 0oC) | 12 weeks after starting the intervention | |
Secondary | Skin blood flow response to acute cooling | Finger Skin blood flow; measurement (using laser Doppler flowmetry) made once finger skin temperature has stabilised in response to localised cooling (in an air temperature of 0oC) | pre-intervention | |
Secondary | Skin blood flow response to acute cooling | Finger Skin blood flow; measurement (using laser Doppler flowmetry) made once finger skin temperature has stabilised in response to localised cooling (in an air temperature of 0oC) | 12 weeks after starting the intervention | |
Secondary | Skin temperature response to re-warming | The time taken for skin temperature of finger to stabilise in an environmental temperature of 25oC following localised cooling (in an air temperature of 0oC) | pre-intervention | |
Secondary | Skin temperature response to re-warming | The time taken for skin temperature of finger to stabilise in an environmental temperature of 25oC following localised cooling (in an air temperature of 0oC) | 12 weeks after starting the intervention | |
Secondary | Skin temperature after re-warming | skin temperature that a finger exposed to an environmental temperature of 25oC stabilises to after localised cooling | pre-intervention | |
Secondary | Skin temperature after re-warming | skin temperature that a finger exposed to an environmental temperature of 25oC stabilises to after localised cooling | 12 weeks after starting the intervention | |
Secondary | Quality of life score | Assessed using SF-36 questionnaire. Responses are coded and normalised to the UK population, as per standard methods, and a score for mental and physical health calculated; a higher score indicating a more favourable outcome | pre-intervention | |
Secondary | Quality of life score | Assessed using SF-36 questionnaire. Responses are coded and normalised to the UK population, as per standard methods, and a score for mental and physical health calculated; a higher score indicating a more favourable outcome | 4 weeks after starting intervention | |
Secondary | Quality of life score | Assessed using SF-36 questionnaire. Responses are coded and normalised to the UK population, as per standard methods, and a score for mental and physical health calculated; a higher score indicating a more favourable outcome | 8 weeks after starting intervention | |
Secondary | Quality of life score | Assessed using SF-36 questionnaire. Responses are coded and normalised to the UK population, as per standard methods, and a score for mental and physical health calculated; a higher score indicating a more favourable outcome | 12 weeks after starting the intervention | |
Secondary | Attrition rate | Number of participants completing the protocol as a proportion of those who were randomised to the study | 2 years | |
Secondary | Adverse events | Any injury, accident or illness experienced over the intervention period will be documented | 3 months | |
Secondary | Recruitment rate | number of people volunteering to take part in the study as a proportion of those expressing initial interest | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03869008 -
Potential Benefit for Non Invasive Vagus Nerve Stimulation Using GammaCore in the Treatment of Raynaud's Phenomena.
|
N/A |