Cognitive PerformanceNCT01794351
Cognitive Effects of 500mg Trans-resveratrol
A study testing Trans-resveratrol in people with Cognitive Performance and Mood, run by Northumbria University at 1 site in United Kingdom.
Trial summary
This study investigated the potentially cognitive enhancing effects of 500mg trans-resveratrol in healthy, young humans. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Mood
- What is being tested?
- Trans-resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35yrs, healthy.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain performance and nutrition research centre, Northumbria university
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: 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.
- Conditions
- Cognitive Performance, Mood
- Being tested
- Trans-resveratrol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-resveratrolDietary supplement
In this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days.
PlaceboOther
Also called Pharmaceutical grade silica
In this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo then resveratrol | Experimental | 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. Receives: Dietary Supplement: Trans-resveratrol; Other: Placebo |
| Resveratrol then placebo | Experimental | 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 Receives: Dietary Supplement: Trans-resveratrol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40mins Post-dose
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.
Measured: 2.5hrs post-dose
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.
Measured: 4hrs post-dose
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.
Measured: 6hrs post-dose
Secondary outcomes (4)
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.
Measured: 40mins post-dose
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.
Measured: 2.5hrs post-dose
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.
Measured: 4hrs pos-dose
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.
Measured: 6hrs post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kennedy, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794351
- Sponsor's protocol ID
- 22P5
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2013
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trans-resveratrol on Cognitive Performance in Healthy, Young Humans: a Double-blind, Placebo-controlled, Crossover Investigation.
- ClinicalTrials.gov ID
- NCT01794351
- Acronym / sponsor ID
- 22P5
- Conditions
- Cognitive Performance, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the potentially cognitive enhancing effects of 500mg trans-resveratrol in healthy, young humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo then resveratrol | Experimental | Dietary Supplement: Trans-resveratrol, Other: PlaceboParticipants 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. |
| Resveratrol then placebo | Experimental | Dietary Supplement: Trans-resveratrol, Other: PlaceboParticipants 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-35yrs, healthy.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-resveratrolIn this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days. | Dietary supplement | Placebo then resveratrol, Resveratrol then placebo |
| PlaceboAlso: Pharmaceutical grade silicaIn this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days. | Other | Placebo then resveratrol, Resveratrol then placebo |
Primary outcome
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.
4 secondary outcomes
Number of participants with altered mood at 40mins post-dose.
Time frame: 40mins post-dose
Number of participants with altered mood at 2.5hrs post-dose
Time frame: 2.5hrs post-dose
Number of participants with altered mood at 4hrs post-dose
Time frame: 4hrs pos-dose
Number of participants with altered mood at 6hrs post-dose
Time frame: 6hrs post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-resveratrol in people with Cognitive Performance and Mood, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with altered cognitive function at 40mins post-dose (time frame: 40mins Post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.