- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01794351
Cognitive Effects of 500mg Trans-resveratrol
February 15, 2013 updated by: David Kennedy, Northumbria University
Effects of Trans-resveratrol on Cognitive Performance in Healthy, Young Humans: a Double-blind, Placebo-controlled, Crossover Investigation.
This study investigated the potentially cognitive enhancing effects of 500mg trans-resveratrol in healthy, young humans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Brain performance and nutrition research centre, Northumbria university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-35yrs, healthy.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Placebo then resveratrol
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.
|
In this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days.
In this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days.
Other Names:
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Experimental: Resveratrol then placebo
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
|
In this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days.
In this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with altered cognitive function at 40mins post-dose
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with altered mood at 40mins post-dose.
Time Frame: 40mins post-dose
|
This outcome was assessed by the number of participants whose baseline mood scores (as assessed by the Bond-Lader mood scale which categorises 'alert', 'content' and 'calm') differed from the 40mins post-dose scores.
|
40mins post-dose
|
Number of participants with altered mood at 2.5hrs post-dose
Time Frame: 2.5hrs post-dose
|
This outcome was assessed by the number of participants whose baseline mood scores (as assessed by the Bond-Lader mood scale which categorises 'alert', 'content' and 'calm') differed from the 2.5hrs post-dose scores.
|
2.5hrs post-dose
|
Number of participants with altered mood at 4hrs post-dose
Time Frame: 4hrs pos-dose
|
This outcome was assessed by the number of participants whose baseline mood scores (as assessed by the Bond-Lader mood scale which categorises 'alert', 'content' and 'calm') differed from the 4hrs post-dose scores.
|
4hrs pos-dose
|
Number of participants with altered mood at 6hrs post-dose
Time Frame: 6hrs post-dose
|
This outcome was assessed by the number of participants whose baseline mood scores (as assessed by the Bond-Lader mood scale which categorises 'alert', 'content' and 'calm') differed from the 6hrs post-dose scores.
|
6hrs post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
February 8, 2013
First Submitted That Met QC Criteria
February 15, 2013
First Posted (Estimate)
February 18, 2013
Study Record Updates
Last Update Posted (Estimate)
February 18, 2013
Last Update Submitted That Met QC Criteria
February 15, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22P5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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