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
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
-
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.