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.
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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 ]


  Serious Adverse Events


  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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