Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2008
Date assigned
20/11/2008
Last edited
17/01/2014
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

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

  1. 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.

Additional files

Editorial Notes