Trial record 4 of 77 for:    resveratrol

The Cognitive and Cerebral Blood Flow Effects of Resveratrol

This study has been completed.
Sponsor:
Information provided by:
Northumbria University
ClinicalTrials.gov Identifier:
NCT01010009
First received: November 6, 2009
Last updated: May 17, 2012
Last verified: May 2012
Results First Received: June 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Cognitive and Cerebral Blood Flow Effects of Resveratrol
Interventions: Dietary Supplement: Trans- resveratrol
Other: Placebo (silica)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Resveratrol 250mg Then Resveratrol 500mg Then Placebo No text entered.
Resveratrol 500mg Then Placebo Then Resveratrol 250mg No text entered.
Placebo Then Resveratrol 250mg Then Resveratrol 500mg No text entered.

Participant Flow:   Overall Study
    Resveratrol 250mg Then Resveratrol 500mg Then Placebo     Resveratrol 500mg Then Placebo Then Resveratrol 250mg     Placebo Then Resveratrol 250mg Then Resveratrol 500mg  
STARTED     8     8     8  
COMPLETED     8     8     8  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Resveratrol 250mg Then Resveratrol 500mg Then Placebo No text entered.
Resveratrol 500mg Then Placebo Then Resveratrol 250mg No text entered.
Placebo Then Resveratrol 250mg Then Resveratrol 500mg No text entered.
Total Total of all reporting groups

Baseline Measures
    Resveratrol 250mg Then Resveratrol 500mg Then Placebo     Resveratrol 500mg Then Placebo Then Resveratrol 250mg     Placebo Then Resveratrol 250mg Then Resveratrol 500mg     Total  
Number of Participants  
[units: participants]
  8     8     8     24  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     8     8     8     24  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  19.2  ± 2.2     21.3  ± 1.8     20  ± 2     20  ± 2  
Gender  
[units: participants]
       
Female     6     7     7     20  
Male     2     1     1     4  
Region of Enrollment  
[units: participants]
       
United Kingdom     8     8     8     24  



  Outcome Measures
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1.  Primary:   Modulation of Levels of Total Haemoglobin   [ Time Frame: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins) ]

2.  Primary:   Modulation of Deoxygenated Levels of Haemoglobin   [ Time Frame: 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins) ]

3.  Secondary:   Number of Participants With Significant Modulation of Cognitive Performance   [ Time Frame: 46-81 mins post dose ]
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Measure Type Secondary
Measure Title Number of Participants With Significant Modulation of Cognitive Performance
Measure Description This outcome measure assessed any significant modulation of cognitive task performance during the 46-81 min post dose period. The cognitive tasks utilized were cognitively demanding computer based, numerical tasks which assessed working memory. Significant modulation is defined as significant difference between baseline and post-dose task performance.
Time Frame 46-81 mins post dose  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Cognitive performance data was analysed for all subjects who completed the trial. If data was not utilized in the final analysis then this was either due to technical issues (i.e. the computer did not save data) or it was clear that the participant had not engaged with the task/s.

Reporting Groups
  Description
Resveratrol 250mg No text entered.
Resveratrol 500mg No text entered.
Placebo No text entered.

Measured Values
    Resveratrol 250mg     Resveratrol 500mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  22     22     22  
Number of Participants With Significant Modulation of Cognitive Performance  
[units: Participants]
  0     0     0  


Statistical Analysis 1 for Number of Participants With Significant Modulation of Cognitive Performance
Groups [1] Resveratrol 250mg vs. Placebo
Method [2] ANOVA
P Value [3] >0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Number of Participants With Significant Modulation of Cognitive Performance
Groups [1] Resveratrol 500mg vs. Placebo
Method [2] ANOVA
P Value [3] >0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Resveratrol 250mg No text entered.
Resveratrol 500mg No text entered.
Placebo No text entered.

Serious Adverse Events
    Resveratrol 250mg     Resveratrol 500mg     Placebo  
Total, serious adverse events        
# participants affected / at risk     0/24 (0.00%)     0/24 (0.00%)     0/24 (0.00%)  




  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Emma Wightman
Organization: Northumbria university
phone: +44 (0) 191 2437253
e-mail: emma.l.wightman@unn.ac.uk


No publications provided


Responsible Party: Emma Wightman, Northumbria University
ClinicalTrials.gov Identifier: NCT01010009     History of Changes
Other Study ID Numbers: 22P2
Study First Received: November 6, 2009
Results First Received: June 26, 2010
Last Updated: May 17, 2012
Health Authority: United Kingdom: Research Ethics Committee