Effect of chocolate with and without polyphenols on health in type 2 diabetes
| ISRCTN | ISRCTN25655161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25655161 |
| Secondary identifying numbers | 1.1 |
- Submission date
- 03/09/2009
- Registration date
- 22/09/2009
- Last edited
- 03/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Brocklehurst Building
220-232 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Study design | Randomised cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Chocolate |
| Primary outcome measure | 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 study start date | 01/01/2007 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Brocklehurst Building
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o James Illingworth
Castle Hill Hospital
Daisy Building
Castle Road
Cottingham
HU16 5JQ
England
United Kingdom
| Website | http://www.hey.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
Hospital/treatment centre
Hull and East Yorkshire Hospitals Diabetes Charitable funds (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 01/11/2010 | Yes | No |
