The effect of dietary intake of Fruit and Vegetables on vascular function in type two Diabetes mellitus
| ISRCTN | ISRCTN21676269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21676269 |
| Secondary identifying numbers | RGHT000151 |
- Submission date
- 12/05/2008
- Registration date
- 20/11/2008
- Last edited
- 17/01/2014
- 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
Dr David McCance
Scientific
Scientific
Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
| Phone | +44 (0)28 9063 3430 |
|---|---|
| david.mccance@belfasttrust.hscni.net |
Study information
| Study design | Randomised, single centre, controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | FVD Study |
| Study objectives | To determine the effect of fruit and vegetable supplementation on measures of vascular function and oxidative stress in type two diabetes mellitus. |
| Ethics approval(s) | Received from the Queens University Belfast Research Ethics Committee in December 2003 (ref: 391/03) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2005 |
| Completion date | 01/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Male or female 2. Aged 40 - 70 years 3. Type two diabetes on diet and/or oral hypoglycaemic therapy |
| Key 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 |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/06/2008 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Regional Centre for Endocrinology and Diabetes
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Royal Victoria Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Research Office
Grosvenor Road
Belfast
BT8 5ZQ
Northern Ireland
United Kingdom
| Phone | +44 (0)28 9063 5372 |
|---|---|
| mary.williams@belfasttrust.hscni.net | |
"ROR" |
https://ror.org/03rq50d77 |
Funders
Funder type
Government
The Research and Development Office of Northern Ireland (UK) (ref: EAT/2933/04)
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 | 14/01/2014 | Yes | No |
