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

Phase 4

Completed

• Conditions: Cerebrovascular Circulation; Cognitive Impairment
• Interventions: Dietary Supplement: Vegetable/fruit juice; Dietary Supplement: Placebo juice

• Registration Number: NCT01169662
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-26
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-11
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vegetable/ Fruit juice	Vegetable/fruit juice	450ml active product, 45 ml no added sugar squash (for flavour)
Placebo juice	Placebo juice	-

Primary Outcome Measures

Name	Time	Method
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.
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
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Northumbria University; 🇬🇧 Newcastle upon Tyne, Tyne & Wear, United Kingdom