Status:
COMPLETED
The Effects of Types of Fruits and Vegetables on Vascular Function
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Imperial College London
Conditions:
Blood Pressure
Vascular Stiffness
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
The CIRCUS study is a randomised controlled, cross-over trial to evaluate the effects of increased intakes of citrus fruits and cruciferous vegetables on vascular function in 36 untreated, prehyperten...
Detailed Description
The study comprises three 14-day dietary intervention periods, preceded by one week run-in period and separated by one week wash-out periods, 9 weeks in total. The diet will be fully controlled and pr...
Eligibility Criteria
Inclusion
- 40 - 65 years
- Average systolic blood pressure of 125-140 mmHg at 2 measurements separated by \>30 minutes
- No use of antihypertensive medication
- No reported current or previous diabetes mellitus, (secondary) hypertension, or metabolic, cardiovascular, renal, liver, thyroid, gastrointestinal diseases
- Body Mass Index between 20 - 35 kg/m2
- Non-smoker
- Average fruit and vegetable consumption of \<4 portions per day (UK average, 40-65 years), or willing to reduce habitual daily fruit and vegetable intake.
Exclusion
- Any medication likely to interfere with energy metabolism, appetite regulation and hormonal balance.
- Excessive alcohol intake of \> 21 units per week (females) or \>28 units per week (male) and not willing to limit alcohol intake to maximum of 1 unit/day
- Physical activity of \>=10 hours/week of moderate to vigorous physical activity
- Weight loss or gain of \>=3 kg in the preceding 3 months
- Use of dietary supplements or unwilling to stop supplement use \>= 2 weeks before enrolment and during intervention
- Pregnancy or lactation
- Intervention specific factors, including:
- Unable or unwilling to consume provided diets during the intervention
- Unsufficient storage space for provided diets
- Food sensitivities or vegetarian/vegan diet by choice
- Participation in another intervention study at the same time
- Living \> 15 miles from the Imperial/NIHR Clinical Research Facility at Hammersmith Hospital
- No signed informed consent
Key Trial Info
Start Date :
September 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03410342
Start Date
September 4 2017
End Date
June 21 2021
Last Update
March 22 2022
Active Locations (2)
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1
Cambridge Epidemiology & Trials Unit
Cambridge, United Kingdom
2
Imperial/NIHR Clinical Research Facility
London, United Kingdom, W12 0HS