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 |
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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) ] |
| 3. Secondary: | Number of Participants With Significant Modulation of Cognitive Performance [ Time Frame: 46-81 mins post dose ] |
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 |