Back to resultsSupplementation of 500mg Trans-resveratrol Within Hypoxic and Normoxic Conditions, in Healthy Humans.
Primary Purpose
Hypoxia, 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, Brain focused on measuring Resveratrol, Cerebral blood flow, Cognition
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
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 Normoixa
Arm Description
500mg of trans-resveratrol, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level.
Pharmaceutical grade fumed silica, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level.
500mg 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) 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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03100019
Brief Title
Supplementation of 500mg Trans-resveratrol Within Hypoxic and Normoxic Conditions, in Healthy Humans.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 13, 2014 (Actual)
Primary Completion Date
April 30, 2015 (Actual)
Study Completion Date
April 30, 2015 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Brain
Keywords
Resveratrol, Cerebral blood flow, Cognition
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
500mg of trans-resveratrol, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level.
Arm Title
Placebo Hypoxia
Arm Type
Placebo Comparator
Arm Description
Pharmaceutical grade fumed silica, tested at a 16% atmospheric oxygen level; the equivalent to 2134m above sea level.
Arm Title
Resveratrol Normoxia
Arm Type
Experimental
Arm Description
500mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.
Arm Title
Placebo Normoixa
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
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Cerebral blood flow
Description
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.
Time Frame
2 hours
Title
Cognitive performance
Description
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.
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:
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.
Exclusion Criteria:
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).
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Supplementation of 500mg Trans-resveratrol Within Hypoxic and Normoxic Conditions, in Healthy Humans.
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