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

This study has been completed.
Sponsor:
Information provided by:
Northumbria University
ClinicalTrials.gov Identifier:
NCT01169662
First received: July 22, 2010
Last updated: October 11, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Cerebrovascular Circulation
Cognitive Impairment
Dietary Supplement: Vegetable/fruit juice
Dietary Supplement: Placebo juice
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters

Further study details as provided by Northumbria University:

Primary Outcome Measures:
  • Change from baseline cerebral blood flow [ Time Frame: From baseline to 2.5 hours post-dose ] [ Designated as safety issue: No ]
    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.

  • Change from baseline cognitive function [ Time Frame: 90 minutes post-dose ] [ Designated as safety issue: No ]
    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

  • Change from baseline mood [ Time Frame: 2.5 hours post-dose ] [ Designated as safety issue: No ]
    Bond-Lader visual analogue mood scales assessing the mood factors 'alert'; 'calm'; and 'content'


Secondary Outcome Measures:
  • Change from baseline blood pressure, heart rate and venous nitrate and nitrite levels [ Time Frame: 2.5 hours post-dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169662

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

No publications provided

Responsible Party: Prof. David Kennedy, Northumbria University
ClinicalTrials.gov Identifier: NCT01169662     History of Changes
Other Study ID Numbers: 24AE1
Study First Received: July 22, 2010
Last Updated: October 11, 2010
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014