The Cognitive and Cerebral Blood Flow Effects of Resveratrol
This study has been completed.
Sponsor:
Northumbria University
Information provided by:
Northumbria University
ClinicalTrials.gov Identifier:
NCT01010009
First received: November 6, 2009
Last updated: May 17, 2012
Last verified: May 2012
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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
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 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
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 | |
|---|---|---|---|---|
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Number of Participants
[units: participants] |
8 | 8 | 8 | 24 |
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Age
[units: participants] |
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| <=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 |
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Gender
[units: participants] |
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| Female | 6 | 7 | 7 | 20 |
| Male | 2 | 1 | 1 | 4 |
|
Region of Enrollment
[units: participants] |
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| United Kingdom | 8 | 8 | 8 | 24 |
Outcome Measures
| 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) ] |
Hide Outcome Measure 2| Measure Type | Primary |
|---|---|
| Measure Title | Modulation of Deoxygenated Levels of Haemoglobin |
| Measure Description | This outcome measure provides the change from baseline values (in µmol/L) of levels of deoxygenated 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. |
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| 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 Deoxygenated Levels of Haemoglobin
[units: µmol/L] Mean ± Standard Error |
0.4 ± 0.2 | 0.2 ± 0.11 | -0.2 ± 0.1 |
Statistical Analysis 1 for Modulation of Deoxygenated Levels of 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: |
|---|---|
| An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA. | |
| [2] | Other relevant 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 Deoxygenated Levels of 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: |
|---|---|
| An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA. | |
| [2] | Other relevant 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. |
| 3. Secondary: | Number of Participants With Significant Modulation of Cognitive Performance [ Time Frame: 46-81 mins post dose ] |
Serious Adverse Events| 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
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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 |
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| 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
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 |