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Completed

NCT Number: NCT01169662

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

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).

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Key information

Conditions

Cerebrovascular Circulation Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vegetable/fruit juice

Dietary Supplement

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

Placebo Juice

Dietary Supplement

50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water.

Primary outcomes

  1. 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.

  2. 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

  3. 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'

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 26, 2010
Registry last updated
Oct 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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