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 |
| Protocol serial number | ELSY No 2870 |
| Sponsor | Hull and East Yorkshire Hospital NHS Trust (UK) |
| Funder | Research and Development Department, Hull Royal Infirmary (UK) |
- Submission date
- 05/01/2007
- Registration date
- 26/01/2007
- Last edited
- 03/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stephen Atkin
Scientific
Scientific
Micheal White Diabetes Centre
Hull Royal Infirmary
Analby Road
Hull
HU3 2RZ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | High polyphenol chocolate |
| Primary outcome measure(s) |
Improvement of fatigue using Chandler Fatigue scale, London Handicap Scale and Hospital Anxiety and Depression Scale. |
| Key secondary outcome measure(s) |
Change in weight |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Micheal White Diabetes Centre
Hull
HU3 2RZ
United Kingdom
HU3 2RZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/11/2010 | Yes | No |
