A comparison of high cocoa solid with absent cocoa solid chocolate in patients with chronic fatigue syndrome in a double blind randomised controlled trial

ISRCTN	ISRCTN03090939
DOI	https://doi.org/10.1186/ISRCTN03090939
Secondary identifying numbers	ELSY No 2870

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Stephen Atkin
Scientific

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

Study design	Double blind randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	High polyphenol chocolate improves symptoms of Chronic Fatigue Syndrome (CFS)
Ethics approval(s)	Hull and East Riding Research Ethics committee on 06/10/2003 (ref: LREC/07/03/121)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	High polyphenol chocolate
Primary outcome measure	Improvement of fatigue using Chandler Fatigue scale, London Handicap Scale and Hospital Anxiety and Depression Scale.
Secondary outcome measures	Change in weight
Overall study start date	01/10/2005
Completion date	01/10/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	10
Key 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)
Key exclusion criteria	1. Benzodiazepine use in the previous two months 2. Unwillilng to give written, informed consent 3. Unable to complete study questionnaires
Date of first enrolment	01/10/2005
Date of final enrolment	01/10/2006

Micheal White Diabetes Centre

Hull
HU3 2RZ
United Kingdom

Hull and East Yorkshire Hospital NHS Trust (UK)
Hospital/treatment centre

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

Website	http://www.hey.nhs.uk/
"ROR"	https://ror.org/01b11x021

Hospital/treatment centre

Research and Development Department, Hull Royal Infirmary (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/11/2010		Yes	No