VEgetableS for vaScular hEaLth: The VESSEL Study

Not Applicable

Completed

• Conditions: Blood pressure; Glycemic control; Inflammation; Oxidative stress; Arterial stiffness; Cardiovascular - Normal development and function of the cardiovascular system; Metabolic and Endocrine - Normal metabolism and endocrine development and function; Inflammatory and Immune System - Normal development and function of the immune system

• Registration Number: ACTRN12619001294145
• Lead Sponsor: Edith Cowan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-19
• Study Completion: 2021-11-26
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

We will recruit ambulant community-dwelling men and women aged between 50 and 75 years who have mildly elevated blood pressure (systolic blood pressure 120-160 mmHg, inclusive, and diastolic blood pressure <100 mmHg).

Exclusion Criteria

Volunteers will be excluded from participation based on the following criteria: body mass index <18.5 or =40 kg/m2; systolic blood pressure >160 mmHg or <120 mm Hg; diastolic blood pressure >100 mmHg; use of >2 antihypertensive medications or irregular use of nitric oxide donors, organic nitrites and nitrates, and sildenafil and related drugs; diagnosed diabetes or fasting blood glucose >6.5 mmol/L; fasting total cholesterol >8 mmol/L; current or recent (<12 months) smoking; adhesive allergy; regular aspirin use; medication use for thrombosis or anticoagulants (Warfarin); history of cardiovascular or peripheral vascular disease (myocardial infarction, stroke, transient ischaemic attack, amputation due to arterial insufficiency, any form of arterial revascularisation, history of exertional angina or claudication); psychiatric illness or other major illnesses, such as cancer; alcohol intake >100 g per week; current or recent (within previous 6 months) significant weight loss or gain (>6% of body weight) or actively trying to lose weight; pre-menopausal women; inability to attend clinic/office visits; use of antibiotics (within previous 2 months); use of antibacterial mouthwash and not willing to cease for trial duration; reported participation in night shift work during the study period; and inability or unwillingness to follow the study protocol. Volunteers with specific dietary requirements, allergies, or intolerances (e.g. following a low FODMAP diet) that will interfere with their ability to follow the dietary requirements of the study will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24 hour ambulatory blood pressure assessed using an Oscar 2TM ambulatory blood pressure monitor (SunTech Medical Inc., Morrisville, NC, USA).[ Ambulatory blood pressure will be assessed at the beginning and end of each intervention period.]