Back to resultsThe Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at Stimulated Altitude.
Primary Purpose
Hypoxia, Altitude, Brain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Hypoxia, Altitude focused on measuring Resveratrol, Cerebral blood flow, Cognition, Hypoxia, Polyphenols
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Resveratrol Hypoxia
Placebo Hypoxia
Resveratrol Normoxia
Placebo Normoxia
Arm Description
500 mg of trans-resveratrol, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000m above sea level.
Pharmaceutical grade fumed silica, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000 m above sea level.
500 mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.
Pharmaceutical grade fumed silica, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03541993
Brief Title
The Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at Stimulated Altitude.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 7, 2016 (Actual)
Primary Completion Date
December 22, 2016 (Actual)
Study Completion Date
December 22, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Altitude, Brain
Keywords
Resveratrol, Cerebral blood flow, Cognition, Hypoxia, Polyphenols
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resveratrol Hypoxia
Arm Type
Experimental
Arm Description
500 mg of trans-resveratrol, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000m above sea level.
Arm Title
Placebo Hypoxia
Arm Type
Placebo Comparator
Arm Description
Pharmaceutical grade fumed silica, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000 m above sea level.
Arm Title
Resveratrol Normoxia
Arm Type
Experimental
Arm Description
500 mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.
Arm Title
Placebo Normoxia
Arm Type
Placebo Comparator
Arm Description
Pharmaceutical grade fumed silica, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cerebral blood flow
Description
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.
Time Frame
2 hours
Title
Cognitive performance
Description
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.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
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.
12. IPD Sharing Statement
Learn more about this trial
The Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at Stimulated Altitude.
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