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

Sponsor
Northumbria University (Other)
Overall Status
Completed
CT.gov ID
NCT01169662
Collaborator
(none)
40
1
2
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Study Details

Study Description

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
  • Dietary Supplement: Vegetable/fruit juice
  • Dietary Supplement: Placebo juice
Phase 4

Study Design

Study Type:
Interventional
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 :
Feb 1, 2010
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline cerebral blood flow [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northumbria University Newcastle upon Tyne Tyne & Wear United Kingdom NE1 8ST

Sponsors and Collaborators

  • Northumbria University

Investigators

  • Principal Investigator: David Kennedy, Northumbria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01169662
Other Study ID Numbers:
  • 24AE1
First Posted:
Jul 26, 2010
Last Update Posted:
Oct 13, 2010
Last Verified:
Oct 1, 2010
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2010