Trial record 4 of 83 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) ]
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Measure Type Primary
Measure Title Modulation of Levels of Total Haemoglobin
Measure Description This outcome measure provides the change from baseline values (in µmol/L) of total levels of haemoglobin during the 46-81 min post dose testing period. This was measured in the frontal cortex by near infrared spectroscopy (NIRS).
Time Frame 0-81 mins (absorption period=1- 45 mins , post dose period 46- 81 mins)  
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.
NIRS data was analysed for all participants who completed the trial and who were not noted as having significantly high or low readings during data collection.

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  
Modulation of Levels of Total Haemoglobin  
[units: µmol/L]
Mean ± Standard Error
  1.9  ± 0.9     2.4  ± 0.8     1.2  ± 0.1  


Statistical Analysis 1 for Modulation of Levels of Total Haemoglobin
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:
  Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.
[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 Modulation of Levels of Total Haemoglobin
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:
  Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.
[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.



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 ]


  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


  Limitations and Caveats
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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
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  More Information