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ISRCTN
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ISRCTN03090939
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ClinicalTrials.gov identifier
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Public title
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A comparison of high cocoa solid with absent cocoa solid chocolate in patients with chronic fatigue syndrome in a double blind randomised controlled trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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ELSY No 2870
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Study hypothesis
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High polyphenol chocolate improves symptoms of Chronic Fatigue Syndrome (CFS).
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Ethics approval
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Favourable opinion given by Hull and East Riding Research Ethics committee on the 6th October 2003 (ref: LREC/07/03/121).
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Study design
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Double blind randomised trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic fatigue syndrome
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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1. Benzodiazepine use in the previous two months
2. Unwillilng to give written, informed consent
3. Unable to complete study questionnaires
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Anticipated start date
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01/10/2005
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Anticipated end date
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01/10/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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10
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Interventions
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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.
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Primary outcome measure(s)
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Improvement of fatigue using Chandler Fatigue scale, London Handicap Scale and Hospital Anxiety and Depression Scale.
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Secondary outcome measure(s)
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Change in weight
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Sources of funding
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Research and Development Department, Hull Royal Infirmary (UK)
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Trial website
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Publications
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Contact name
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Prof
Stephen
Atkin
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Address
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Micheal White Diabetes Centre
Hull Royal Infirmary
Analby Road
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City/town
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Hull
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Zip/Postcode
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HU3 2RZ
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Country
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United Kingdom
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Sponsor
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Hull and East Yorkshire Hospital NHS Trust (UK)
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Address
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c/o Mrs Nina Dunham
Research and Development Department
Castle Hill Hospital
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City/town
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Hull
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Zip/Postcode
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HU16 5JQ
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Country
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United Kingdom
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Sponsor website:
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http://www.hey.nhs.uk/
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Date applied
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05/01/2007
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Last edited
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26/01/2007
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Date ISRCTN assigned
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26/01/2007
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