Contact information
Type
Scientific
Primary contact
Dr David McCance
ORCID ID
Contact details
Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
+44 (0)28 9063 3430
david.mccance@belfasttrust.hscni.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000151
Study information
Scientific title
Acronym
FVD Study
Study hypothesis
To determine the effect of fruit and vegetable supplementation on measures of vascular function and oxidative stress in type two diabetes mellitus.
Ethics approval
Received from the Queens University Belfast Research Ethics Committee in December 2003 (ref: 391/03)
Study design
Randomised, single centre, controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type two diabetes and vascular disease
Intervention
There is a four-week washout period where all 80 subjects take only one portion of fruit and vegetables per day. The subjects are then randomised to either one or six portions of fruit or vegetables for the next eight weeks. The total duration of the trial is 12 weeks for each subject.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Change in endothelial function as measured by venous occlusion plethsymography and pulse wave analysis/velocity.
Secondary outcome measures
Change in biochemical measures of vascular function:
1. Total cholesterol
2. High density lipoprotein (HDL)-cholesterol
3. High sensitivity C-reactive protein (CRP)
4. Triglycerides
5. Plasma plasminogen activator inhibitor-1 (PAI-1)
6. Von Willebrand Factor
7. Plasma glucose
8. Serum insulin
9. HbA1c
10. Adhesion molecules
The subjects undergo assessment of vascular function at the end of the four-week washout period and the eight-week intervention period.
Overall trial start date
01/11/2005
Overall trial end date
01/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male or female
2. Aged 40 - 70 years
3. Type two diabetes on diet and/or oral hypoglycaemic therapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Any acute coronary event or surgery within the previous three months
2. Pregnant or lactating
3. Excess alcohol consumption (greater than 2 units/day for women, greater than 3 units/day for men)
4. Food sensitivities that would interfere with tolerance of fruit and vegetable consumption
5. Medical conditions that would substantially limit their ability to complete the study requirements
6. Ingestion of oral vitamins within the previous four weeks
Recruitment start date
01/11/2005
Recruitment end date
01/06/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Royal Victoria Hospital (UK)
Sponsor details
Royal Research Office
Grosvenor Road
Belfast
BT8 5ZQ
United Kingdom
+44 (0)28 9063 5372
mary.williams@belfasttrust.hscni.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
The Research and Development Office of Northern Ireland (UK) (ref: EAT/2933/04)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24423117
Publication citations
-
Results
Daniels JA, Mulligan C, McCance D, Woodside JV, Patterson C, Young IS, McEneny J, A randomised controlled trial of increasing fruit and vegetable intake and how this influences the carotenoid concentration and activities of PON-1 and LCAT in HDL from subjects with type 2 diabetes., Cardiovasc Diabetol, 2014, 13, 16, doi: 10.1186/1475-2840-13-16.