search
Back to results

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

Primary Purpose

Cerebrovascular Circulation, Cognitive Impairment

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Vegetable/fruit juice
Placebo juice
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebrovascular Circulation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vegetable/ Fruit juice

Placebo juice

Arm Description

450ml active product, 45 ml no added sugar squash (for flavour)

Outcomes

Primary Outcome Measures

Change from baseline cerebral blood flow
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
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
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
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.

Full Information

First Posted
July 22, 2010
Last Updated
October 11, 2010
Sponsor
Northumbria University
search

1. Study Identification

Unique Protocol Identification Number
NCT01169662
Brief Title
Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
Official Title
Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northumbria University

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Circulation, Cognitive Impairment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vegetable/ Fruit juice
Arm Type
Active Comparator
Arm Description
450ml active product, 45 ml no added sugar squash (for flavour)
Arm Title
Placebo juice
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vegetable/fruit juice
Intervention Description
450ml active juice, 45ml no added sugar fruit squash (for flavour)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo juice
Intervention Description
50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water.
Primary Outcome Measure Information:
Title
Change from baseline cerebral blood flow
Description
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.
Time Frame
From baseline to 2.5 hours post-dose
Title
Change from baseline cognitive function
Description
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
Time Frame
90 minutes post-dose
Title
Change from baseline mood
Description
Bond-Lader visual analogue mood scales assessing the mood factors 'alert'; 'calm'; and 'content'
Time Frame
2.5 hours post-dose
Secondary Outcome Measure Information:
Title
Change from baseline blood pressure, heart rate and venous nitrate and nitrite levels
Description
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.
Time Frame
2.5 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kennedy
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northumbria University
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26037632
Citation
Wightman EL, Haskell-Ramsay CF, Thompson KG, Blackwell JR, Winyard PG, Forster J, Jones AM, Kennedy DO. Dietary nitrate modulates cerebral blood flow parameters and cognitive performance in humans: A double-blind, placebo-controlled, crossover investigation. Physiol Behav. 2015 Oct 1;149:149-58. doi: 10.1016/j.physbeh.2015.05.035. Epub 2015 May 31.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs