NCT03815162

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). Participants will be randomised to consume either high flavanol cocoa extract or low flavanol cocoa (placebo) daily for 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

November 4, 2021

Status Verified

November 1, 2021

Enrollment Period

1.5 years

First QC Date

January 18, 2019

Last Update Submit

November 3, 2021

Conditions

Primary Raynaud Phenomenon

Keywords

cocoa flavanols

Outcome Measures

Primary Outcomes (1)

  • Vasospasm

    frequency of vasospasm

    3 months

Secondary Outcomes (30)

  • Severity of vasospasm symptoms

    3 months

  • Duration of vasospasm symptoms

    3 months

  • Raynaud's Condition score

    3 months

  • Blood pressure

    pre-intervention

  • Blood pressure

    4 weeks after starting intervention

  • +25 more secondary outcomes

Study Arms (2)

High Flavanol Cocoa extract

EXPERIMENTAL

278mg total flavanols (38.3mg epicatechin) per opaque cellulose capsule 3 capsules consumed once per day (836 mg total flavanols; 115mg epicatechin) for 3 months

Dietary Supplement: High Flavanol Cocoa extract

Alkalised cocoa

PLACEBO COMPARATOR

0mg total flavanols (0mg epicatechin) per opaque cellulose capsule 3 capsules consumed once per day (0mg total flavanols; 0mg epicatechin) for 3 months

Dietary Supplement: Alkalised cocoa

Interventions

High Flavanol Cocoa extractDIETARY_SUPPLEMENT

Experimental group

High Flavanol Cocoa extract
Alkalised cocoaDIETARY_SUPPLEMENT

Control group

Alkalised cocoa

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Greenfield Human Physiology Laboratories

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (2)

  • Herrick A. Raynaud's phenomenon. Curr Treat Options Cardiovasc Med. 2008 Apr;10(2):146-55. doi: 10.1007/s11936-008-0016-y.

    PMID: 18325317BACKGROUND

  • 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.

    PMID: 19248104BACKGROUND

Study Officials

  • Ian A Macdonald, PhD

    University of Nottingham

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Opaque capsules of equal size and appearance presented in similar bottles labelled only by a code. Code to product information is held by the manufacturer and un-blinding of the PI will only occur once the study analysis has been completed or in the event of a serious adverse event occurring.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double-blinded, placebo controlled study. Block randomised with equal allocation of participants between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 24, 2019

Study Start

October 16, 2018

Primary Completion

April 30, 2020

Study Completion

July 31, 2021

Last Updated

November 4, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Individual data will not be shared with other researchers

Locations

GB(1)