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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169662
• Other study ID #: 24AE1
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2010
• Last updated: October 11, 2010
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cerebrovascular Circulation
• Cognition Disorders
• Cognitive Impairment

Intervention

Dietary Supplement:
• Vegetable/fruit juice
450ml active juice, 45ml no added sugar fruit squash (for flavour)
• Placebo juice
50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water.

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne	Tyne & Wear

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 2.5 hours post-dose	No
Primary	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	90 minutes post-dose	No
Primary	Change from baseline mood	Bond-Lader visual analogue mood scales assessing the mood factors 'alert'; 'calm'; and 'content'	2.5 hours post-dose	No
Secondary	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.	2.5 hours post-dose	No