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A dose response study of the effects of increased fruit and vegetables intake on vascular function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50011192
Enrollment
48
Registered
2005-09-09
Start date
2004-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elevated blood pressure Circulatory System Elevated blood pressure

Interventions

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

Sponsors

Food Standards Agency (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Blood Pressure

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026