A dose response study of the effects of increased fruit and vegetables intake on vascular function
| ISRCTN | ISRCTN50011192 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50011192 |
| Secondary identifying numbers | N2030 |
- Submission date
- 25/08/2005
- Registration date
- 09/09/2005
- Last edited
- 06/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Thomas Sanders
Scientific
Scientific
Nutritional Sciences Research Division
King's College London
150 Stamford Street
London
SE1 9NH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | DRFRUITNVEG |
| Study objectives | This study will address the hypothesis that: 1. An increase in potassium intake as fruit and vegetables by 20 to 40 mmol/day will lower blood pressure and that beyond this threshold level there will be no further reduction in blood pressure 2. An increase in fruit and vegetable intake will have beneficial effects on arterial compliance and endothelial function 3. That the effect is attributable to an increase in potassium intake |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Elevated blood pressure |
| Intervention | The dietary intervention will compare three levels of fruit and vegetable intake to supply additional potassium intakes of 0, 20 and 40 mmol/day of potassium versus an additional 40 mmol/day provided as a supplement. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fruit and vegetables |
| Primary outcome measure | Blood Pressure |
| Secondary outcome measures | 1. Pulse Wave Velocity 2. Endothelial Function (flow mediated dilatation) 3. Biochemical indices of endothelial function |
| Overall study start date | 01/10/2004 |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 |
| Key inclusion criteria | Subjects will be male or female, non-smoking and aged between 22-65 years. A principal aim is to identify and recruit subjects with moderate elevation of Blood Pressure (BP). Eligible subjects will have diastolic more than 80 mmHg and less than 100 mmHg and a systolic BP of less than 160 mmHg. |
| Key exclusion criteria | 1. Current smokers 2. A reported history of myocardial infarction or cancer 3. Diabetes mellitus (fasting plasma glucose more than 7 mmol/l) 4. Recent use of oral hypolipidaemic therapy, systemic corticosteroids, androgens, phenytoin, erythromycin or thyroid hormones 5. Current use of antihypertensive medication 6. Those receiving drugs for regulating haemostasis but excluding aspirin or who have been exposed to any investigational agent within 30 days of the study 7. Chronic coronary, renal or bowel disease or history of cholestatic liver disease or pancreatitis 8. Presence of gastrointestinal disorder or use of a drug, which is likely to alter gastrointestinal motility or nutrient absorption 9. History of substance abuse or alcoholism 10. Currently pregnant, planning pregnancy, or having had a baby in the last 12 months 11. Allergy or intolerance to intervention foods 12. Unwilling to follow the protocol and/or give informed consent 13. Unwilling to refrain from use of dietary supplements 14. Weight loss at more than 3 kg in preceding two months 15. Alcohol intake not exceeding a moderate intake of (less than 24 - 36 g/day) 16. Body Mass Index more than 20 and less than 35 kg/m^2 17. Subjects with a blood pressure and other risk factors that make them eligible for drug treatment of raised blood pressure according to the UK guidelines of the British Hypertension Society |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nutritional Sciences Research Division
London
SE1 9NH
United Kingdom
SE1 9NH
United Kingdom
Sponsor information
Food Standards Agency (UK)
Government
Government
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom
| Website | http://www.food.gov.uk |
|---|---|
"ROR" |
https://ror.org/05p20a626 |
Funders
Funder type
Government
Food Standards Agency Project (reference number: N02030)
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 | 01/12/2010 | Yes | No |
