Effect of chocolate with and without polyphenols on health in type 2 diabetes

ISRCTN	ISRCTN25655161
DOI	https://doi.org/10.1186/ISRCTN25655161
Protocol serial number	1.1
Sponsor	Hull and East Yorkshire Hospitals NHS Trust (UK)
Funder	Hull and East Yorkshire Hospitals Diabetes Charitable funds (UK)

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

Brocklehurst Building
220-232 Anlaby Road
Hull
HU3 2RW
United Kingdom

Primary study design	Interventional
Study design	Randomised cross-over trial
Secondary study design	Randomised controlled trial
Scientific title	Crossover randomised controlled trial studying the effects of chocolate with and without polyphenols in type 2 diabetes
Study acronym	ChocDM1
Study objectives	Eating high polyphenol chocolate can reduce cardiovascular risk in type 2 diabetes.
Ethics approval(s)	Hull and East Riding Local Research Ethics Committee, approved on 21/11/2006 (ref: 06/Q1104/128)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Chocolate
Primary outcome measure(s)	Lipid profile All outcome measures were measured at baseline, 8 weeks (following intervention 1), 12 weeks (following washout) and 20 weeks (following intervention 2).
Key secondary outcome measure(s)	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).
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Both males and females, ages 18 and above 2. Type 2 diabetes 3. Stable medication
Key exclusion criteria	Changes in medication over the past 3 months
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2008

Brocklehurst Building

Hull
HU3 2RW
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2010		Yes	No