Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.1
Study information
Scientific title
Crossover randomised controlled trial studying the effects of chocolate with and without polyphenols in type 2 diabetes
Acronym
ChocDM1
Study hypothesis
Eating high polyphenol chocolate can reduce cardiovascular risk in type 2 diabetes.
Ethics approval
Hull and East Riding Local Research Ethics Committee, approved on 21/11/2006 (ref: 06/Q1104/128)
Study design
Randomised cross-over trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Not Specified
Patient information sheet
Condition
Type 2 diabetes
Intervention
Subjects were given either 45 g per day of high polyphenol chocolate or low polyphenol chocolate for 2 months. Following 1 month washout they were switched to the other chocolate.
Intervention type
Drug
Phase
Not Applicable
Drug names
Chocolate
Primary outcome measures
Lipid profile
All outcome measures were measured at baseline, 8 weeks (following intervention 1), 12 weeks (following washout) and 20 weeks (following intervention 2).
Secondary outcome measures
Homeostatic Model Assessment (HOMA) index
All outcome measures were measured at baseline, 8 weeks (following intervention 1), 12 weeks (following washout) and 20 weeks (following intervention 2).
Overall trial start date
01/01/2007
Overall trial end date
01/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, ages 18 and above
2. Type 2 diabetes
3. Stable medication
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
Changes in medication over the past 3 months
Recruitment start date
01/01/2007
Recruitment end date
01/01/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brocklehurst Building
Hull
HU3 2RW
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
c/o James Illingworth
Castle Hill Hospital
Daisy Building
Castle Road
Cottingham
HU16 5JQ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hull and East Yorkshire Hospitals Diabetes Charitable funds (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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20968113
Publication citations
-
Results
Mellor DD, Sathyapalan T, Kilpatrick ES, Beckett S, Atkin SL, High-cocoa polyphenol-rich chocolate improves HDL cholesterol in Type 2 diabetes patients., Diabet. Med., 2010, 27, 11, 1318-1321.