Status:
COMPLETED
Cocoa Flavanol Supplementation in Raynaud's Phenomenon
Lead Sponsor:
University of Nottingham
Conditions:
Primary Raynaud Phenomenon
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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). Partici...
Detailed Description
Primary Raynaud's phenomenon (PRP) is characterised by periodic vasospasm of the fingers and toes precipitated by exposure to cold or emotional stimuli and stress. Previous studies have demonstrated t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03815162
Start Date
October 16 2018
End Date
July 31 2021
Last Update
November 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
David Greenfield Human Physiology Laboratories
Nottingham, Notts, United Kingdom, NG72UH