Hypoxia, BrainNCT03100019
Supplementation of 500mg Trans-resveratrol Within Hypoxic and Normoxic Conditions, in Healthy Humans.
A study testing Resveratrol in people with Hypoxia, Brain, run by Northumbria University.
Trial summary
Objectives: Resveratrol, a non-flavonoid polyphenol, has been found to consistently modulate cerebral blood flow (CBF) following oral supplementation. Although, this has not resulted in subsequent predicted benefits to cognitive performance in young healthy populations. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Brain
- What is being tested?
- Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 13 May 2014to 30 Apr 2015
- Phase
- Interventional
- 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
- Participants who gave informed consent.
- Those who didn't meet any of the exclusion criteria.
- Those who took hormonal contraception (e.g.: the pill, coil, implant, etc.) were allow to participate in the current study.
Who cannot join
- Smokers.
- People below 18 or above 35 years old at the time of giving consent
- People with Body Mass Index outside of the range 18-35 kg/m2.
- People with blood pressure greater than 140/90 HH/mg
- People who have been living (for more than 3 months) at an altitude of 2000 m or over within the past 6 months.
- People with a history of neurological, vascular or psychiatric illness (excluding depressive illness and anxiety).
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- People with a current diagnosis of depression and/or anxiety.
- Participants with learning difficulties, dyslexia or colour blindness.
- Participants with visual impairment that cannot be corrected with glasses or contact lenses.
- Participants with frequent migraines that require medication (more than or equal to 1 per month).
- Participants with disorders of the blood.
- Participants with a heart disorder.
- Participants with a respiratory disorder that requires regular medication (Note: asthma sufferers who only take their medication occasionally/as required are eligible for this study).
- Participants with diabetes.
- Participants with any food intolerances/sensitivities.
- Women who are pregnant, or seeking to become pregnant, or are currently lactating.
- Participants currently taking any prescription medications.
- Participants who have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total).
- Participants with a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g., iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation.
- Participants with any health condition that would prevent fulfilment of the study requirements.
About this study
Official title: The Effects of Acute Trans-resveratrol Supplementation on Aspects of Cognitive Function and Cerebral Blood Flow, During Hypoxia and Normoxia, in Healthy, Young Humans.
Objectives: Resveratrol, a non-flavonoid polyphenol, has been found to consistently modulate cerebral blood flow (CBF) following oral supplementation. Although, this has not resulted in subsequent predicted benefits to cognitive performance in young healthy populations. However, it is argued that those who suffer a reduction in CBF and cognition, such as aging populations, may benefit more from resveratrol administration.
Hypothesis: The current investigation aimed to employ a mild hypoxia as an experimental model of aging in a young healthy population, to assess if resveratrol can attenuate the deficits elicited by the reduction in oxygen supply. It was hypothesized resveratrol would module CBF, to provide a more efficient supply of oxygen to overcome any associated decreases to performance caused by the hypoxic model.
Read more
Design: This repeated measures, double blind, placebo controlled, balanced design assessed the cognitive and CBF effects of resveratrol in hypoxia (equivalent to ~2000m above sea level) and normoxia (sea level).
Methods: 24 participants arrived fully fasted (except water) for 12 hrs before completing a baseline measure of a cognitive task battery, and taking the treatment for the day. Following a 45 min absorption period, participants completed 3 full repetitions of the cognitive test battery and, if appropriate, the oxygen level was altered. Changes in CBF were measured by near-infrared spectroscopy throughout the full testing session.
- Conditions
- Hypoxia, Brain
- Being tested
- Resveratrol, Placebo
- Keywords
- Resveratrol, Cerebral blood flow, Cognition
- Medical subject headings
- Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol Hypoxia | Experimental | 500mg of trans-resveratrol, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level. Receives: Dietary Supplement: Resveratrol |
| Placebo Hypoxia | Placebo comparator | Pharmaceutical grade fumed silica, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level. Receives: Drug: Placebo |
| Resveratrol Normoxia | Experimental | 500mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level. Receives: Dietary Supplement: Resveratrol |
| Placebo Normoixa | Placebo comparator | Pharmaceutical grade fumed silica, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Cerebral heamodynamic response (of the prefrontal cortex) at rest and during task performance (all concentration change (μmol / L)).
There are 3 outputs to this (oxygenated, de-oxygenated and total heamoglobin, detailing changes of oxygenation and de-oxygenation in the neural tissue at rest and during task performance.
Measured: 2 hours
Cognitive performance
Participants completed a number of tasks to measure cognitive domain performance (Episodic Memory, Speed of Attention, \& Accuracy of Attention), as part of a 15 minute cognitive battery. Outcomes were measured in accuracy of responses to each task (% correct), reaction time to respond to each task (in milliseconds (ms), and the number of error responses when completing each task.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start13 May 2014
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, BrainStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Eschle, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100019
- Sponsor's protocol ID
- 22AX1
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acute Trans-resveratrol Supplementation on Aspects of Cognitive Function and Cerebral Blood Flow, During Hypoxia and Normoxia, in Healthy, Young Humans.
- ClinicalTrials.gov ID
- NCT03100019
- Acronym / sponsor ID
- 22AX1
- Conditions
- Hypoxia, Brain
- Keywords
- Resveratrol, Cerebral blood flow, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 13 May 2014 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Objectives: Resveratrol, a non-flavonoid polyphenol, has been found to consistently modulate cerebral blood flow (CBF) following oral supplementation. Although, this has not resulted in subsequent predicted benefits to cognitive performance in young healthy populations. However, it is argued that those who suffer a reduction in CBF and cognition, such as aging populations, may benefit more from resveratrol administration.
Hypothesis: The current investigation aimed to employ a mild hypoxia as an experimental model of aging in a young healthy population, to assess if resveratrol can attenuate the deficits elicited by the reduction in oxygen supply. It was hypothesized resveratrol would module CBF, to provide a more efficient supply of oxygen to overcome any associated decreases to performance caused by the hypoxic model.
Design: This repeated measures, double blind, placebo controlled, balanced design assessed the cognitive and CBF effects of resveratrol in hypoxia (equivalent to ~2000m above sea level) and normoxia (sea level).
Methods: 24 participants arrived fully fasted (except water) for 12 hrs before completing a baseline measure of a cognitive task battery, and taking the treatment for the day. Following a 45 min absorption period, participants completed 3 full repetitions of the cognitive test battery and, if appropriate, the oxygen level was altered. Changes in CBF were measured by near-infrared spectroscopy throughout the full testing session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resveratrol Hypoxia | Experimental | Dietary Supplement: Resveratrol500mg of trans-resveratrol, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level. |
| Placebo Hypoxia | Placebo comparator | Drug: PlaceboPharmaceutical grade fumed silica, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level. |
| Resveratrol Normoxia | Experimental | Dietary Supplement: Resveratrol500mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level. |
| Placebo Normoixa | Placebo comparator | Drug: PlaceboPharmaceutical grade fumed silica, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who gave informed consent.
- Those who didn't meet any of the exclusion criteria.
- Those who took hormonal contraception (e.g.: the pill, coil, implant, etc.) were allow to participate in the current study.
Key exclusion criteria (20 listed)
- Smokers.
- People below 18 or above 35 years old at the time of giving consent
- People with Body Mass Index outside of the range 18-35 kg/m2.
- People with blood pressure greater than 140/90 HH/mg
- People who have been living (for more than 3 months) at an altitude of 2000 m or over within the past 6 months.
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 |
|---|---|---|
| Resveratrol | Dietary supplement | Resveratrol Hypoxia, Resveratrol Normoxia |
| Placebo | Drug | Placebo Hypoxia, Placebo Normoixa |
Primary outcome
Cerebral blood flow
Time frame: 2 hours
Cerebral heamodynamic response (of the prefrontal cortex) at rest and during task performance (all concentration change (μmol / L)). There are 3 outputs to this (oxygenated, de-oxygenated and total heamoglobin, detailing changes of oxygenation and de-oxygenation in the neural tissue at rest and during task performance.
Cognitive performance
Time frame: 1 hour
Participants completed a number of tasks to measure cognitive domain performance (Episodic Memory, Speed of Attention, \& Accuracy of Attention), as part of a 15 minute cognitive battery. Outcomes were measured in accuracy of responses to each task (% correct), reaction time to respond to each task (in milliseconds (ms), and the number of error responses when completing each task.
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 4 Apr 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol in people with Hypoxia, Brain, run by Northumbria University.
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 3 inclusion and 20 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Cerebral blood flow (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2017.