Condition category
Circulatory System
Date applied
25/08/2005
Date assigned
09/09/2005
Last edited
06/01/2011
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

Prof Thomas Sanders

ORCID ID

Contact details

Nutritional Sciences Research Division
King's College London
150 Stamford Street
London
SE1 9NH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N2030

Study information

Scientific title

Acronym

DRFRUITNVEG

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Fruit and vegetables

Primary outcome measures

Blood Pressure

Secondary outcome measures

1. Pulse Wave Velocity
2. Endothelial Function (flow mediated dilatation)
3. Biochemical indices of endothelial function

Overall trial start date

01/10/2004

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant 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

Recruitment start date

01/10/2004

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nutritional Sciences Research Division
London
SE1 9NH
United Kingdom

Sponsor information

Organisation

Food Standards Agency (UK)

Sponsor details

Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom

Sponsor type

Government

Website

http://www.food.gov.uk

Funders

Funder type

Government

Funder name

Food Standards Agency Project (reference number: N02030)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20673378

Publication citations

  1. Results

    Berry SE, Mulla UZ, Chowienczyk PJ, Sanders TA, Increased potassium intake from fruit and vegetables or supplements does not lower blood pressure or improve vascular function in UK men and women with early hypertension: a randomised controlled trial., Br. J. Nutr., 2010, 104, 12, 1839-1847, doi: 10.1017/S0007114510002904.

Additional files

Editorial Notes