LFV
Other1 apple/banana/small bunch of grapes per day plus 1 portion of carrot/pepper/tomato per day
NCT Number: NCT03410342
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.
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Notify Me40 year–65 year
All sexes
Interventional
Not applicable
Cambridge Epidemiology & Trials Unit, Cambridge, United Kingdom
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 apple/banana/small bunch of grapes per day plus 1 portion of carrot/pepper/tomato per day
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.
4 portions of citrus fruits (clementines, grapefruits, lemons, oranges) plus 4 portions of cruciferous vegetables (broccoli, brussels sprouts, cauliflower, kale, savoy cabbage) per day.
Time frame: 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
Changes in systolic and diastolic blood pressure (mmHg) measured by automated oscillometric device (average of 3 measurements).
Time frame: 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
Changes (end minus baseline values) in arterial stiffness (pulse wave analysis)
Time frame: 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
e.g. high-density lipoprotein
Time frame: 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
e.g. C-Reactive Protein
Time frame: 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
e.g. Interleukin-6
Time frame: 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
(Un)targeted metabolic profiling by NMR and MS
Time frame: 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
(Un)targeted metabolic profiling by NMR and MS
Time frame: 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
e.g. vitamin C
Time frame: 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
Measured by 16SrRNA gene sequencing
Time frame: 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
e.g. Stroop-test
Time frame: 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
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.
University of Cambridge
Other
The Effects of Types of Fruits and Vegetables on Vascular Function in Prehypertensive Participants: a Pilot Study
Acronym: CIRCUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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