The Time Effects of a Berry Extract Upon Cerebral Blood Flow.
| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 6, 2012 |
| Last Updated Date | November 23, 2012 |
| Start Date ICMJE | February 2012 |
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01540123 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | The Time Effects of a Berry Extract Upon Cerebral Blood Flow. |
| Official Title ICMJE | The Time Effects of a Berry Extract Upon Cerebral Blood Flow. |
| Brief Summary | Berry fruits are widely recognised as natural functional food products. They contain several different phytochemicals which have potential to modulate human health and wellbeing. There is however some debate regarding the mechanisms driving their health promoting properties. Despite the wide health promoting properties of fruit extracts reported in the literature, considerable interest over the past decade has primarily been focused on their roles in reducing risk factors associated with cancer and heart disease. Consequently, there remains a paucity of actual scientific information on their role in modulating brain functions, such as mood, learning and memory, any decrements of which have very negative impacts on the quality of life. Fruit phytochemicals from other sources have been shown to mediate both peripheral and cerebral blood flow. However, a modulation of cerebral blood flow has not been shown with berries as yet. Cerebral blood flow must be maintained to ensure a constant delivery of oxygen and glucose as well as the removal of waste products. The modulation of cerebral blood flow via supplementation of berry polyphenols could therefore be a potential way to positively modulate human cognitive behavior. The link between acute increases in cerebral blood flow and increased cognition is currently a little weak but it could give a good platform for long term behavioral and health benefits via increased cerebral/peripheral blood flow and decreased MAO-B activity. The aims of the study are therefore to investigate the impact of the berry extract on digital volume pulse, blood pressure and cerebral blood flow. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Condition ICMJE | Cerebral Blood Flow |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Recruiting |
| Estimated Enrollment ICMJE | 20 |
| Estimated Completion Date | May 2013 |
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years to 35 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | United Kingdom |
| Administrative Information | |
| NCT Number ICMJE | NCT01540123 |
| Other Study ID Numbers ICMJE | 28AI3 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Anthony Watson, Northumbria University |
| Study Sponsor ICMJE | Northumbria University |
| Collaborators ICMJE | The New Zealand Institute for Plant and Food Research |
| Investigators ICMJE | Not Provided |
| Information Provided By | Northumbria University |
| Verification Date | November 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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