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

NCT01169662 | Completed Phase 4

• 1 other identifier: 24AE1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebrovascular Circulation; Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Change from baseline mood

  Bond-Lader visual analogue mood scales assessing the mood factors 'alert'; 'calm'; and 'content'

  2.5 hours post-dose

Secondary Outcomes (1)

• Change from baseline blood pressure, heart rate and venous nitrate and nitrite levels

  2.5 hours post-dose

Study Arms (2)

Vegetable/ Fruit juice

ACTIVE COMPARATOR

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

Dietary Supplement: Vegetable/fruit juice

Placebo juice

PLACEBO COMPARATOR

Dietary Supplement: Placebo juice

Interventions

Vegetable/fruit juice DIETARY_SUPPLEMENT

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

Vegetable/ Fruit juice

Placebo juice DIETARY_SUPPLEMENT

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

Placebo juice

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy young (18-35 years) male and female adults, not vulnerable.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Northumbria University

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

Location

Related Publications (1)

• 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.

  PMID: 26037632 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Vegetables; Fruit and Vegetable Juices

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages

Study Officials

• David Kennedy

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

GB (1)