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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01169662
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : October 13, 2010
Information provided by:
Northumbria University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Cerebrovascular Circulation Cognitive Impairment Dietary Supplement: Vegetable/fruit juice Dietary Supplement: Placebo juice Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
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)

Placebo Comparator: Placebo juice Dietary Supplement: Placebo juice
50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water.

Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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'

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01169662

United Kingdom
Northumbria University
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST
Sponsors and Collaborators
Northumbria University
Principal Investigator: David Kennedy Northumbria University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. David Kennedy, Northumbria University Identifier: NCT01169662     History of Changes
Other Study ID Numbers: 24AE1
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders