NCT03541993

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

April 9, 2018

Last Update Submit

May 29, 2018

Conditions

Keywords

ResveratrolCerebral blood flowCognitionHypoxiaPolyphenols

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 hour

Study Arms (4)

Resveratrol Hypoxia

EXPERIMENTAL

500 mg of trans-resveratrol, tested at a 12.7% atmospheric oxygen level; the equivalent to 4000m above sea level.

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.

Other: Placebo

Resveratrol Normoxia

EXPERIMENTAL

500 mg of trans-resveratrol, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.

Dietary Supplement: Resveratrol

Placebo Normoxia

PLACEBO COMPARATOR

Pharmaceutical grade fumed silica, tested at a 20.9% atmospheric oxygen level; the equivalent to sea level.

Other: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT
Resveratrol HypoxiaResveratrol Normoxia
PlaceboOTHER
Placebo HypoxiaPlacebo Normoxia

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who provided informed consent.

You may not qualify if:

  • Those who took hormonal contraception (e.g.: the pill, coil, implant, etc.) were eligible to participate in the current study.
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Altitude SicknessHypoxia

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2018

First Posted

May 31, 2018

Study Start

June 7, 2016

Primary Completion

December 22, 2016

Study Completion

December 22, 2016

Last Updated

May 31, 2018

Record last verified: 2018-05