Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters

October 11, 2010 updated by: Northumbria University
Nitrate provides the body with an alternative source of Nitric Oxide which plays a large role in promoting blood flow and reducing blood pressure. Nitrate supplementation with vegetable/fruit juice has recently been shown to reduce blood pressure and reduce energy expenditure during low intensity exercise. Such findings combined with the previously known biological effects of nitric oxide would suggest that nitrate supplementation would also impact on blood flow. The aim of this study is to examine the effects of dietary nitrate supplementation via vegetable/fruit juice drink on cerebral (brain) blood flow (using Near Infrared Spectroscopy).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
        • Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy young (18-35 years) male and female adults, not vulnerable.

Exclusion Criteria:

  • smoke or consume any tobacco products (even occasionally)
  • not proficient in English
  • pregnant (or are seeking to become)
  • currently taking recreational, over the counter/prescription medication (excluding the contraceptive pill), and/or dietary/herbal supplements.
  • any food allergies or sensitivities that are relevant to the study
  • history of/current head trauma, learning difficulties, ADHD, dyslexia, migraines or any gastric problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo juice
Dietary supplement: Placebo juice
50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water.
Active Comparator: Vegetable/ Fruit juice
450ml active product, 45 ml no added sugar squash (for flavour)
Dietary supplement: Vegetable/fruit juice
450ml active juice, 45ml no added sugar fruit squash (for flavour)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline cerebral blood flow
Time Frame: From baseline to 2.5 hours post-dose
Near infrared spectroscopy monitoring of cerebral blood flow in the frontal cortex during demanding tasks. Monitored from baseline, through 90 minutes of drink absorption and 60 minutes of cognitive task performance.
From baseline to 2.5 hours post-dose
Change from baseline cognitive function
Time Frame: 90 minutes post-dose
Performance of the cognitive demand battery (CDB), which assesses aspects of psychomotor speed, working memory and executive function. The CDB involves 6 repetitions of the following tasks: serial three subtractions (2 mins); serial seven subtractions (2 mins); Rapid Visual Information Processing (5 mins) and a subjective rating of mental fatigue
90 minutes post-dose
Change from baseline mood
Time Frame: 2.5 hours post-dose
Bond-Lader visual analogue mood scales assessing the mood factors 'alert'; 'calm'; and 'content'
2.5 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline blood pressure, heart rate and venous nitrate and nitrite levels
Time Frame: 2.5 hours post-dose
Diastolic and systolic blood pressure and heart rate monitored after completion of cognitive tasks to assess peripheral blood flow effects. Plasma nitrate and nitrite levels assessed at 2.5 hours post-dose.
2.5 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Investigators

  • Principal Investigator: David Kennedy, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Estimate)

October 13, 2010

Last Update Submitted That Met QC Criteria

October 11, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24AE1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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