NCT01010009

Brief Summary

Research shows that resveratrol is able to induce vasodilation (and therefore blood flow) by interacting with nitric oxide (NO). Research also shows that acute administration of metabolic substrates, like oxygen and glucose, can enhance aspects of cognitive performance in young, healthy humans. The aim of this investigation was to determine if the consumption of resveratrol could modulate cerebral blood flow and if this in turn could influence cognitive performance by increasing access to blood borne metabolic fuel. Results showed that compared to placebo, after consuming 500mg pure trans-resveratrol, levels of total haemoglobin were significantly higher in the frontal cortex of young, healthy participants during cognitive task completion. Cognitive performance was not effected.

Trial Health

87
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 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 18, 2011

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

9 months

First QC Date

November 6, 2009

Results QC Date

June 26, 2010

Last Update Submit

May 17, 2012

Conditions

Keywords

resveratrolcerebral blood flowNIRScognitive performance

Outcome Measures

Primary Outcomes (2)

  • Modulation of Levels of Total Haemoglobin

    This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).

    0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)

  • Modulation of Deoxygenated Levels of Haemoglobin

    This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).

    0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)

Secondary Outcomes (1)

  • Number of Participants With Significant Modulation of Cognitive Performance

    46-81 mins post dose

Study Arms (3)

Resveratrol 250mg

EXPERIMENTAL
Dietary Supplement: Trans- resveratrolOther: Placebo (silica)

Resveratrol 500mg

EXPERIMENTAL
Dietary Supplement: Trans- resveratrolOther: Placebo (silica)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Trans- resveratrolOther: Placebo (silica)

Interventions

Trans- resveratrolDIETARY_SUPPLEMENT

All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.

Also known as: Transmax from Biotivia.
PlaceboResveratrol 250mgResveratrol 500mg

All 24 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 500mg resveratrol or placebo on separate days (with a 48hr-14day wash out period between each treatment) with the order dictated by a latin square. Treatment was administered in capsule form and in a double blind manner.

Also known as: Pharmaceutical grade silica
PlaceboResveratrol 250mgResveratrol 500mg

Eligibility Criteria

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

You may qualify if:

  • Male/female,
  • Healthy
  • Age 18-35 years old
  • Non smoker
  • Proficient in English
  • Not taking any herbal or prescription medications
  • Not pregnant
  • Does not drink more than 6 cups of coffee per day

You may not qualify if:

  • Suffered a head injury, neurological disorder or neuro-developmental disorder
  • Food allergies/intolerances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

ResveratrolSilicon Dioxide

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenolsMineralsInorganic ChemicalsOxidesOxygen CompoundsSilicon Compounds

Results Point of Contact

Title
Emma Wightman
Organization
Northumbria university

Study Officials

  • Crystal Haskell

    Northumbria University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

June 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 23, 2012

Results First Posted

April 18, 2011

Record last verified: 2012-05

Locations