Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
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|ClinicalTrials.gov Identifier: NCT01169662|
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : October 13, 2010
|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|
|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|
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.
- 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.
- 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
- 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'
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01169662
|Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 8ST|
|Principal Investigator:||David Kennedy||Northumbria University|