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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

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 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

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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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).

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

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