The Effects of Types of Fruits and Vegetables on Vascular Function

NCT03410342 | Completed

• 2 other identifiers: 17HH3878Research Ethics Committee
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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, prehypertensive participants.

Conditions

Blood Pressure; Vascular Stiffness; Cardiovascular Risk Factor

Keywords

Blood Pressure; Vascular Stiffness; Cardiovascular Risk Factor; Fruit and vegetable

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Arterial stiffness

  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

  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

  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

  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

  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

Study Arms (3)

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.

Other: LFV

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.

Other: HFV

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.

Other: CC

Interventions

LFV OTHER

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

Low Fruits and Vegetables (LFV)

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.

High Fruits and Vegetables (HFV)

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.

High Citrus fruits and Cruciferous vegetables (CC)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cambridge: lead
• Imperial College London: collaborator

Study Sites (2)

Cambridge Epidemiology & Trials Unit

Cambridge, United Kingdom

Location

Imperial/NIHR Clinical Research Facility

London, W12 0HS, United Kingdom

Location

Study Officials

• Linda Oude Griep, PhD

  MRC Epidemiology Unit, University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Associate

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: January 25, 2018
• Study Start: September 4, 2017
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: In a timely manner when results have been published in peer-reviewed journals.

Locations

GB (2)