Effect of High Nitrate Vegetable Juice Supplementation on Plasma Nitrate and Blood Pressure in Healthy Adults

NCT04736784 | Completed

• 1 other identifier: QUB 16.60
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: The aim of this study is to carry out a randomised crossover intervention study examining the effect of two different high nitrate vegetable juices on plasma nitrate levels and blood pressure (BP) in healthy adults. Objectives: 1) to conduct a pilot cross-over randomized intervention study testing the hypothesis that the health benefits of two different high nitrate vegetable juices products will be similar; 2) to measure the volunteers' BP as the primary outcome; and 3) to collect biological samples over the course of this study for the measurement of proposed biomarkers of nutritional status, including plasma nitrate.

Conditions

Blood Pressure

Keywords

nitrate rich juices; blood pressure

Outcome Measures

Primary Outcomes (4)

• Blood pressure (clinic-based)

  Clinic-based blood pressure using automated, calibrated blood pressure monitor, measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.

  At baseline

• Blood pressure (clinic-based)

  Clinic-based blood pressure using automated, calibrated blood pressure monitor, measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.

  After seven days

• Blood pressure (home-assessed)

  An automated BP monitor (Omron M2Basic, Omron Healthcare) will be provided to each participant to measure daily resting BP at home. Participants will be asked to conduct duplicate measurements, in a seated position prior to juice consumption and at 2 hours after juice drinking and they will be trained on how to use the monitor, with an emphasis on the correct positioning of the cuff and arm. In addition, written instructions on measuring BP will be provided. Participants will be provided with a record sheet to record their measurements.

  Pre juice consumption during the intervention

• Blood pressure (home-assessed)

  An automated BP monitor (Omron M2Basic, Omron Healthcare) will be provided to each participant to measure daily resting BP at home. Participants will be asked to conduct duplicate measurements, in a seated position prior to juice consumption and at 2 hours after juice drinking and they will be trained on how to use the monitor, with an emphasis on the correct positioning of the cuff and arm. In addition, written instructions on measuring BP will be provided. Participants will be provided with a record sheet to record their measurements.

  Two hours post juice consumption during the intervention

Secondary Outcomes (3)

• Serum nitrate and nitrite concentrations

  At baseline

• Serum nitrate and nitrite concentrations

  After seven days

• Participant views on interventions

  At end of the seven day intervention

Study Arms (2)

Beetroot juice

EXPERIMENTAL

115 ml of beetroot juice per day for seven days

Other: Food-based - beetroot juice

Leafy green vegetable juice

EXPERIMENTAL

250 ml of green leafy vegetable juice per day for seven days

Other: Food-based - leafy green vegetable juice

Interventions

Food-based - beetroot juice OTHER

Beetroot juice containing approximately 340 mg nitrate daily

Beetroot juice

Food-based - leafy green vegetable juice OTHER

Leafy green vegetable juice containing approximately 340 mg nitrate daily

Leafy green vegetable juice

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Aged 30-65 years

You may not qualify if:

• Diabetes mellitus
• An acute coronary syndrome or transient ischaemic attack within the past 3 months
• Special dietary requirements, food sensitivities or vegetarian/ vegan diet by choice
• Oral anticoagulation therapy
• Recent beetroot juice (or other nitrate) supplementation.
• BMI\>35 kg/m2
• Excessive alcohol consumption ( \>14 U/week for men and women)
• Current smoker
• Pregnancy/ lactation
• Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Centre for Public Health, Queen's University Belfast

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Location

Study Officials

• Jayne Woodside

  Queen's University, Belfast

  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: Professor

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 3, 2021
• Study Start: January 30, 2017
• Primary Completion: April 30, 2017
• Study Completion: May 15, 2017
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)