Condition category
Nervous System Diseases
Date applied
05/01/2007
Date assigned
26/01/2007
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

Micheal White Diabetes Centre
Hull Royal Infirmary
Analby Road
Hull
HU3 2RZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ELSY No 2870

Study information

Scientific title

Acronym

Study hypothesis

High polyphenol chocolate improves symptoms of Chronic Fatigue Syndrome (CFS)

Ethics approval

Hull and East Riding Research Ethics committee on 06/10/2003 (ref: LREC/07/03/121)

Study design

Double blind randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic fatigue syndrome

Intervention

Double blind cross over study using chocolate containing high polyphenols with low polyphenol chocolate with two weeks washout, eight weeks of initial intervention and eight weeks of cross-over intervention.

Intervention type

Drug

Phase

Not Specified

Drug names

High polyphenol chocolate

Primary outcome measures

Improvement of fatigue using Chandler Fatigue scale, London Handicap Scale and Hospital Anxiety and Depression Scale.

Secondary outcome measures

Change in weight

Overall trial start date

01/10/2005

Overall trial end date

01/10/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age group 18 to 35
2. Diagnosis of CFS as defined by the Centers for Disease Control (CDC) criteria
3. Severity of fatigue - a score of at least ten (out of 11) on the Chalder-Fatigue Scale (binary scored)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Benzodiazepine use in the previous two months
2. Unwillilng to give written, informed consent
3. Unable to complete study questionnaires

Recruitment start date

01/10/2005

Recruitment end date

01/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Micheal White Diabetes Centre
Hull
HU3 2RZ
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospital NHS Trust (UK)

Sponsor details

c/o Mrs Nina Dunham
Research and Development Department
Castle Hill Hospital
Hull
HU16 5JQ
United Kingdom

Sponsor type

Government

Website

http://www.hey.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Research and Development Department, Hull Royal Infirmary (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21092175

Publication citations

  1. Results

    Sathyapalan T, Beckett S, Rigby AS, Mellor DD, Atkin SL, High cocoa polyphenol rich chocolate may reduce the burden of the symptoms in chronic fatigue syndrome., Nutr J, 2010, 9, 55, doi: 10.1186/1475-2891-9-55.

Additional files

Editorial Notes