Blood Pressure Clinical Trial
— CIRCUSOfficial title:
The Effects of Types of Fruits and Vegetables on Vascular Function in Prehypertensive Participants: a Pilot Study
Verified date | March 2022 |
Source | University of Cambridge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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, prehypertensive participants.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 21, 2021 |
Est. primary completion date | June 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge Epidemiology & Trials Unit | Cambridge | |
United Kingdom | Imperial/NIHR Clinical Research Facility | London |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge | Imperial College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood pressure | Changes in systolic and diastolic blood pressure (mmHg) measured by automated oscillometric device (average of 3 measurements). | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Arterial stiffness | Changes (end minus baseline values) in arterial stiffness (pulse wave analysis) | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Markers of cardiometabolic health measured in fasted blood samples | e.g. high-density lipoprotein | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Markers of endothelial function measured in fasted blood samples | e.g. C-Reactive Protein | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Markers of low-grade inflammation measured in fasted blood samples | e.g. Interleukin-6 | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Urinary metabolic profiles | (Un)targeted metabolic profiling by NMR and MS | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Circulatory metabolic profiles | (Un)targeted metabolic profiling by NMR and MS | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Established objective markers of food intake | e.g. vitamin C | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Faecal microbiome composition | Measured by 16SrRNA gene sequencing | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Cognitive function | e.g. Stroop-test | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks | |
Secondary | Self-rated general health and mental well-being | e.g. Positive and Negative Affect Schedule (PANAS) that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a Likert scale of 1 (not at all) to 5 (very much). Positive and negative affect scores are added seperately to a reange from 10 to 50. Higher positive scores represents higher levels of positive affect. Lower negative scores respresaent lower levels of negative affect. | Measured on the morning after each of three recurring run-in periods and after each of three recurring 2-week intervention periods, 6 times total during 9 weeks |
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