Cognitive Effects of 500mg Trans-resveratrol

Mood Clinical Trial

Official title:

Effects of Trans-resveratrol on Cognitive Performance in Healthy, Young Humans: a Double-blind, Placebo-controlled, Crossover Investigation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794351
• Other study ID #: 22P5
• 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

• Cognitive Performance
• Mood

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