Cerebrovascular CirculationPhase 4NCT01169662
Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
A Phase 4 study testing Vegetable/fruit juice in people with Cerebrovascular Circulation and Cognitive Impairment, run by Northumbria University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Circulation, Cognitive Impairment
- What is being tested?
- Vegetable/fruit juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy young (18-35 years) male and female adults, not vulnerable.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST
About this study
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
- Being tested
- Vegetable/fruit juice, Placebo juice
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetable/fruit juiceDietary supplement
450ml active juice, 45ml no added sugar fruit squash (for flavour)
Placebo juiceDietary supplement
50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water.
| Study group | Role | What they receive |
|---|---|---|
| Vegetable/ Fruit juice | Active comparator | 450ml active product, 45 ml no added sugar squash (for flavour) Receives: Dietary Supplement: Vegetable/fruit juice |
| Placebo juice | Placebo comparator | Not described Receives: Dietary Supplement: Placebo juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 90 minutes post-dose
Change from baseline mood
Bond-Lader visual analogue mood scales assessing the mood factors 'alert'; 'calm'; and 'content'
Measured: 2.5 hours post-dose
Secondary outcomes (1)
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.
Measured: 2.5 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Investigators
- David Kennedy, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169662
- Sponsor's protocol ID
- 24AE1
- Status last verified
- Oct 2010
- First submitted
- 22 Jul 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26037632
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Nitrate From Vegetable/Fruit Juice on Cerebral Blood Flow Parameters
- ClinicalTrials.gov ID
- NCT01169662
- Acronym / sponsor ID
- 24AE1
- Conditions
- Cerebrovascular Circulation, Cognitive Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegetable/ Fruit juice | Active comparator | Dietary Supplement: Vegetable/fruit juice450ml active product, 45 ml no added sugar squash (for flavour) |
| Placebo juice | Placebo comparator | Dietary Supplement: Placebo juice |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy young (18-35 years) male and female adults, not vulnerable.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegetable/fruit juice450ml active juice, 45ml no added sugar fruit squash (for flavour) | Dietary supplement | Vegetable/ Fruit juice |
| Placebo juice50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water. | Dietary supplement | Placebo juice |
Primary outcome
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'
1 secondary outcome
Change from baseline blood pressure, heart rate and venous nitrate and nitrite levels
Time frame: 2.5 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- Derived from this study: PubMed 26037632Wightman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kennedy principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vegetable/fruit juice in people with Cerebrovascular Circulation and Cognitive Impairment, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cerebral blood flow (time frame: From baseline to 2.5 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01169662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.