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Completed

NCT Number: NCT03410342

The Effects of Types of Fruits and Vegetables on Vascular Function

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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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Epidemiology & Trials Unit, Cambridge, United Kingdom

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About this study

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:

  • 1 portion of fruits plus 1 portion of vegetables, of commonly consumed types per day. Intakes are at 25th percentile of UK consumption and will exclude citrus fruits, cruciferous and allium vegetables.
  • 4 portions of fruits plus 4 portions of vegetables, of commonly consumed types per day excluding citrus fruits, cruciferous and allium vegetables.
  • 4 portions of citrus fruits plus 4 portions of cruciferous vegetables per day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LFV

Other

1 apple/banana/small bunch of grapes per day plus 1 portion of carrot/pepper/tomato per day

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.

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.

Primary outcomes

  1. Blood pressure

    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).

Secondary outcomes

  1. Arterial stiffness

    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)

  2. Markers of cardiometabolic health measured in fasted blood samples

    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

  3. Markers of endothelial function measured in fasted blood samples

    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

  4. Markers of low-grade inflammation measured in fasted blood samples

    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

  5. Urinary metabolic profiles

    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

  6. Circulatory metabolic profiles

    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

  7. Established objective markers of food intake

    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

  8. Faecal microbiome composition

    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

  9. Cognitive function

    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

  10. Self-rated general health and mental well-being

    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.

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • Imperial College London

Registry information

Official study title

The Effects of Types of Fruits and Vegetables on Vascular Function in Prehypertensive Participants: a Pilot Study

Acronym: CIRCUS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2018
Registry last updated
Mar 22, 2022

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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