Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Northumbria University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change from baseline cerebral blood flow
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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'
Secondary Outcomes
- Change from baseline blood pressure, heart rate and venous nitrate and nitrite levels(2.5 hours post-dose)