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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21092175
Publication citations
-
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.