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
Protocol serial number	RGHT000151
Sponsor	Royal Victoria Hospital (UK)
Funder	The Research and Development Office of Northern Ireland (UK) (ref: EAT/2933/04)

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

Regional Centre for Endocrinology and Diabetes
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Phone	+44 (0)28 9063 3430
Email	david.mccance@belfasttrust.hscni.net

Study information

Primary study design	Interventional
Study design	Randomised, single centre, controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Change in endothelial function as measured by venous occlusion plethsymography and pulse wave analysis/velocity.
Key secondary outcome measure(s)	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.
Completion date	01/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
Northern Ireland

Study participating centre

Regional Centre for Endocrinology and Diabetes

Belfast
BT12 6BA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes