CompletedNot Applicable

Cocoa Flavanol Supplementation in Raynaud's Phenomenon

United Kingdom27 participantsStarted 2018-10-16

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Vasospasm

Timeframe: 3 months

Trial details

NCT IDNCT03815162

SponsorUniversity of Nottingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-30

View on ClinicalTrials.gov More Primary Raynaud Phenomenon trials