Hypoxia, AltitudeNCT03541993
The Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at Stimulated Altitude.
A study testing Resveratrol in people with Hypoxia, Altitude and Brain, run by Northumbria University.
Trial summary
Background: Vaso-active polyphenols have been proposed to enhance cognitive performance. Oral administration with the non-flavonoid polyphenol, resveratrol, has been found to modulate cerebral blood flow (CBF); yet, this has not resulted in subsequent predicted benefits to cognitive performance in young, healthy… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Altitude, 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
- 7 Jun 2016to 22 Dec 2016
- 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
- Individuals who provided 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 eligible to participate in the current study.
Who cannot join
- Individuals below 18 years or above 35 years old at the time of giving consent.
- Individuals with Body Mass Index outside of the range 18-35 kg/m2.
- Individuals with blood pressure greater than 140/90 HH/mg.
- Those who smoke or have smoked.
- Individuals who have been living (for more than 3 months) at an altitude of 2000 m or over within the past 6 months.
- Individuals with a history of neurological, vascular or psychiatric illness (excluding depressive illness and anxiety).
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- Individuals with a current diagnosis of depression and/or anxiety.
- Individuals with relevant learning difficulties, dyslexia, dyscalculia or colour blindness.
- Individuals with visual impairment that cannot be corrected with glasses or contact lenses.
- Individuals with frequent migraines that require medication (more than or equal to 1 per month).
- Individuals with disorders of the blood.
- Individuals with a heart disorder.
- Individuals with a respiratory disorder that requires regular medication (Note: asthma sufferers who only take their medication occasionally/as required are eligible for this study).
- Individuals with diabetes.
- Individuals with any food intolerances/sensitivities.
- Females participants who were pregnant, seeking to become pregnant, or currently lactating.
- Individuals currently taking any prescription medications.
- Individuals who have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total).
- Individuals 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.
- Individuals with any health condition that would prevent fulfilment of the study requirements.
About this study
Official title: The Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at 4000 m Stimulated Altitude and at Sea Level: A Double Blind, Crossover Investigation.
Background: Vaso-active polyphenols have been proposed to enhance cognitive performance. Oral administration with the non-flavonoid polyphenol, resveratrol, has been found to modulate cerebral blood flow (CBF); yet, this has not resulted in subsequent predicted benefits to cognitive performance in young, healthy samples. It has been argued that ageing populations who are noted suffer a reduction in CBF and cognition, may possess the subtle deficits to benefit from resveratrol administration. The use of hypoxia has been previously tested by this research group to mimic the decrease in cognitive functioning associated with ageing.
Objectives: The current investigation aimed to further assess if a reduced fraction of inspired oxygen (12.7% FiO2) could provide an experimental model of aging in a young, healthy sample. Moreover, the current study also aimed to assess if resveratrol can attenuate the deficits elicited by the reduction in oxygen supply via increased CBF.
Read more
Design: This repeated measures, double blind, placebo controlled, balanced design assessed the cognitive and CBF effects of resveratrol in hypoxia (equivalent to 4000 m above sea level) and normoxia (sea level).
Methods: Twenty-four participants arrived fully fasted (except water) for 12 hours before completing a baseline measure of a cognitive task battery, and taking the treatment for the day (either 500 mg resveratrol or inert placebo). Following a 45 min absorption period, participants completed 3 full repetitions of a cognitive test battery. Changes in cerebral hemodynamics were measured by near-infrared spectroscopy throughout the full testing session.
- Conditions
- Hypoxia, Altitude, Brain
- Being tested
- Resveratrol, Placebo
- Keywords
- Resveratrol, Cerebral blood flow, Cognition, Hypoxia, Polyphenols
- Medical subject headings
- Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol Hypoxia | Experimental | 500 mg of trans-resveratrol, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000m above sea level. Receives: Dietary Supplement: Resveratrol |
| Placebo Hypoxia | Placebo comparator | Pharmaceutical grade fumed silica, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000 m above sea level. Receives: Other: Placebo |
| Resveratrol Normoxia | Experimental | 500 mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level. Receives: Dietary Supplement: Resveratrol |
| Placebo Normoxia | Placebo comparator | Pharmaceutical grade fumed silica, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level. Receives: Other: 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) was measured at rest and during task performance. The outputs measured here were: oxygenated and deoxygenated haemoglobin concentrations. The addition of these two outputs can also detail total haemoglobin, a proxy for cerebral blood flow. All outputs were reported as concentration change in μmol / L.
Measured: 2 hours
Cognitive performance
Participants completed a number of tasks to measure cognitive performance (as represented by the three main cognitive domains impacted by hypoxia (Memory, Speed of Attention, \& Accuracy of Attention)), as part of a 15-minute cognitive battery. Cognitive tasks were scored for accuracy of responses (% correct) and the reaction time to respond to each correct response (in milliseconds (ms)). With the exception of the memory tasks which were scored for the number of correct responses and for the number error responses. Scores across the multiple cognitive tasks were combined to represent the three overall cognitive domains outlined above.
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 posted31 May 2018
- Study start7 Jun 2016
- Primary completion22 Dec 2016
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, AltitudeStudies 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
- NCT03541993
- Sponsor's protocol ID
- 42AX2
- Status last verified
- May 2018
- First submitted
- 9 Apr 2018
- Last updated
- 31 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at 4000 m Stimulated Altitude and at Sea Level: A Double Blind, Crossover Investigation.
- ClinicalTrials.gov ID
- NCT03541993
- Acronym / sponsor ID
- 42AX2
- Conditions
- Hypoxia, Altitude, Brain
- Keywords
- Resveratrol, Cerebral blood flow, Cognition, Hypoxia, Polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 31 May 2018 (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.
Background: Vaso-active polyphenols have been proposed to enhance cognitive performance. Oral administration with the non-flavonoid polyphenol, resveratrol, has been found to modulate cerebral blood flow (CBF); yet, this has not resulted in subsequent predicted benefits to cognitive performance in young, healthy samples. It has been argued that ageing populations who are noted suffer a reduction in CBF and cognition, may possess the subtle deficits to benefit from resveratrol administration. The use of hypoxia has been previously tested by this research group to mimic the decrease in cognitive functioning associated with ageing.
Objectives: The current investigation aimed to further assess if a reduced fraction of inspired oxygen (12.7% FiO2) could provide an experimental model of aging in a young, healthy sample. Moreover, the current study also aimed to assess if resveratrol can attenuate the deficits elicited by the reduction in oxygen supply via increased CBF.
Design: This repeated measures, double blind, placebo controlled, balanced design assessed the cognitive and CBF effects of resveratrol in hypoxia (equivalent to 4000 m above sea level) and normoxia (sea level).
Methods: Twenty-four participants arrived fully fasted (except water) for 12 hours before completing a baseline measure of a cognitive task battery, and taking the treatment for the day (either 500 mg resveratrol or inert placebo). Following a 45 min absorption period, participants completed 3 full repetitions of a cognitive test battery. Changes in cerebral hemodynamics 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: Resveratrol500 mg of trans-resveratrol, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000m above sea level. |
| Placebo Hypoxia | Placebo comparator | Other: PlaceboPharmaceutical grade fumed silica, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000 m above sea level. |
| Resveratrol Normoxia | Experimental | Dietary Supplement: Resveratrol500 mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level. |
| Placebo Normoxia | Placebo comparator | Other: 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)
- Individuals who provided 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 eligible to participate in the current study.
Key exclusion criteria (20 listed)
- Individuals below 18 years or above 35 years old at the time of giving consent.
- Individuals with Body Mass Index outside of the range 18-35 kg/m2.
- Individuals with blood pressure greater than 140/90 HH/mg.
- Those who smoke or have smoked.
- Individuals 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 | Other | Placebo Hypoxia, Placebo Normoxia |
Primary outcome
Cerebral blood flow
Time frame: 2 hours
Cerebral heamodynamic response (of the prefrontal cortex) was measured at rest and during task performance. The outputs measured here were: oxygenated and deoxygenated haemoglobin concentrations. The addition of these two outputs can also detail total haemoglobin, a proxy for cerebral blood flow. All outputs were reported as concentration change in μmol / L.
Cognitive performance
Time frame: 1 hour
Participants completed a number of tasks to measure cognitive performance (as represented by the three main cognitive domains impacted by hypoxia (Memory, Speed of Attention, \& Accuracy of Attention)), as part of a 15-minute cognitive battery. Cognitive tasks were scored for accuracy of responses (% correct) and the reaction time to respond to each correct response (in milliseconds (ms)). With the exception of the memory tasks which were scored for the number of correct responses and for the number error responses. Scores across the multiple cognitive tasks were combined to represent the three overall cognitive domains outlined above.
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 31 May 2018.
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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, Altitude and 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 31 May 2018. 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 31 May 2018.