Cognitive Effects of 500mg Trans-resveratrol

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ClinicalTrials.gov Identifier: NCT01794351

Recruitment Status : Completed

First Posted : February 18, 2013

Last Update Posted : February 18, 2013

Sponsor:

Information provided by (Responsible Party):

David Kennedy, Northumbria University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cognitive Performance Mood	Dietary Supplement: Trans-resveratrol Other: Placebo	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Basic Science
Official Title:	Effects of Trans-resveratrol on Cognitive Performance in Healthy, Young Humans: a Double-blind, Placebo-controlled, Crossover Investigation.
Study Start Date :	October 2012
Actual Primary Completion Date :	December 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

U.S. FDA Resources

Arms and Interventions

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.	Dietary Supplement: Trans-resveratrol In this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days. Other: Placebo In this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days. Other Name: Pharmaceutical grade silica
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	Dietary Supplement: Trans-resveratrol In this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days. Other: Placebo In this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days. Other Name: Pharmaceutical grade silica

Outcome Measures

Primary Outcome Measures :

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.
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.
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.
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.

Secondary Outcome Measures :

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.
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.
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.
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794351

Locations


United Kingdom
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST

Sponsors and Collaborators

Northumbria University

More Information


Responsible Party:	David Kennedy, Professor, Northumbria University
ClinicalTrials.gov Identifier:	NCT01794351 History of Changes
Other Study ID Numbers:	22P5
First Posted:	February 18, 2013 Key Record Dates
Last Update Posted:	February 18, 2013
Last Verified:	February 2013

Additional relevant MeSH terms:


Resveratrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents	Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Antimutagenic Agents Anticarcinogenic Agents

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