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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01794351
Other study ID # 22P5
Secondary ID
Status Completed
Phase N/A
First received February 8, 2013
Last updated February 15, 2013
Start date October 2012
Est. completion date December 2012

Study information

Verified date February 2013
Source Northumbria University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United Kingdom Brain performance and nutrition research centre, Northumbria university Newcastle upon Tyne Tyne and Wear

Sponsors (1)

Lead Sponsor Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Number of participants with altered mood at 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 No
Secondary Number of participants with altered mood at 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 No
Secondary Number of participants with altered mood at 4hrs 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 4hrs post-dose scores. 4hrs pos-dose No
Secondary Number of participants with altered mood at 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 No
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