NCT01794351

Brief Summary

This study investigated the potentially cognitive enhancing effects of 500mg trans-resveratrol in healthy, young humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

February 8, 2013

Last Update Submit

February 15, 2013

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of participants with altered cognitive function at 40mins post-dose

    This outcome measure is assessed by the number of participants whose scores on a range of cognitive tasks (word and picture recall and recognition, serial 3s and 7s subtractions, rapid visual information processing (RVIP), N-Back (3-Back version), Stroop and numeric working memory) differed from the baseline to 40min post-dose scores.

    40mins Post-dose

  • Number of participants with altered cognitive function at 2.5hrs post-dose

    This outcome measure is assessed by the number of participants whose scores on a range of cognitive tasks (word and picture recall and recognition, serial 3s and 7s subtractions, rapid visual information processing (RVIP), N-Back (3-Back version), Stroop and numeric working memory) differed from baseline to the 2.5hr post-dose scores.

    2.5hrs post-dose

  • Number of participants with altered cognitive function at 4hrs post-dose

    This outcome measure is assessed by the number of participants whose scores on a range of cognitive tasks (word and picture recall and recognition, serial 3s and 7s subtractions, rapid visual information processing (RVIP), N-Back (3-Back version), Stroop and numeric working memory) differed from baseline to the 4hr post-dose scores.

    4hrs post-dose

  • Number of participants with altered cognitive function at 6hrs post-dose

    This outcome measure is assessed by the number of participants whose scores on a range of cognitive tasks (word and picture recall and recognition, serial 3s and 7s subtractions, rapid visual information processing (RVIP), N-Back (3-Back version), Stroop and numeric working memory) differed from baseline to the 6hr post-dose scores.

    6hrs post-dose

Secondary Outcomes (4)

  • Number of participants with altered mood at 40mins post-dose.

    40mins post-dose

  • Number of participants with altered mood at 2.5hrs post-dose

    2.5hrs post-dose

  • Number of participants with altered mood at 4hrs post-dose

    4hrs pos-dose

  • Number of participants with altered mood at 6hrs post-dose

    6hrs post-dose

Study Arms (2)

Placebo then resveratrol

EXPERIMENTAL

Participants in this arm (decided according to Latin square) first received placebo and then resveratrol, on seperate days, with a 7-14 day wash-out period between visits.

Dietary Supplement: Trans-resveratrolOther: Placebo

Resveratrol then placebo

EXPERIMENTAL

Participants in this arm (decided according to Latin square) first received resveratrol and then placebo, on seperate days, with a 7-14 day wash-out period between visits

Dietary Supplement: Trans-resveratrolOther: Placebo

Interventions

Trans-resveratrolDIETARY_SUPPLEMENT

In this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days.

Placebo then resveratrolResveratrol then placebo
PlaceboOTHER

In this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days.

Also known as: Pharmaceutical grade silica
Placebo then resveratrolResveratrol then placebo

Eligibility Criteria

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

You may qualify if:

  • yrs, healthy.

You may not qualify if:

  • Drug/alcohol abuse, taking prescription medication (apart from contraception) or herbal supplements, having food intolerances or allergies, having suffered a head-injury or neurological/neuro-developmental disorder, uncorrected sight problems, pregnant or seeking to become so, excessive caffeine use (e.g. more than 6 cups of coffee per day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain performance and nutrition research centre, Northumbria university

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 18, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations