Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/09/2009
Date assigned
22/09/2009
Last edited
03/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

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

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

http://www.hey.nhs.uk

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

  1. 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.

Additional files

Editorial Notes