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| ID | Type | Description | Link |
|---|---|---|---|
| Research Ethics Committee | Registry Identifier | 17/LO/0862 |
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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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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.
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 provided by the researchers. Participants will receive in random order three interventions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Fruits and Vegetables (LFV) | Placebo Comparator | 1 portion of fruits plus 1 portion of vegetables, of commonly consumed types per day. Intakes are at 25th percentile of UK consumption (NDNS) and will exclude citrus fruits, cruciferous and allium vegetables. |
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| High Fruits and Vegetables (HFV) | Experimental | 4 portions of fruits plus 4 portions of vegetables, of commonly consumed types per day excluding citrus fruits, cruciferous and allium vegetables. |
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| High Citrus fruits and Cruciferous vegetables (CC) | Experimental | 4 portions of citrus fruits plus 4 portions of cruciferous vegetables per day excluding any other types of fruits and vegetables including allium vegetables. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFV | Other | 1 apple/banana/small bunch of grapes per day plus 1 portion of carrot/pepper/tomato per day |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Markers of cardiometabolic health measured in fasted blood samples |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Oude Griep, PhD | MRC Epidemiology Unit, University of Cambridge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge Epidemiology & Trials Unit | Cambridge | United Kingdom | ||||
| Imperial/NIHR Clinical Research Facility |
As describe in study protocol
In a timely manner when results have been published in peer-reviewed journals.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2019 | Mar 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2022 | Mar 7, 2022 | SAP_001.pdf |
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| HFV | Other | 4 portions of fruits (apples, bananas, grapes, pears) plus 4 portions of vegetables (carrots, cucumber, sweet peppers, tomatoes), of commonly consumed types per day excluding citrus fruits, cruciferous and allium vegetables. |
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| CC | Other | 4 portions of citrus fruits (clementines, grapefruits, lemons, oranges) plus 4 portions of cruciferous vegetables (broccoli, brussels sprouts, cauliflower, kale, savoy cabbage) per day. |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| London |
| W12 0HS |
| United Kingdom |