Cognitive and Cerebral Blood Flow Effects of Vitamin C
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| First Received Date ICMJE | January 22, 2010 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Endothelial function (using cerebral blood flow as a proxy measurement as measured by TCD and NIRS. [ Time Frame: ~100 mins ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01055418 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cognitive performance [ Time Frame: ~50 mins ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cognitive and Cerebral Blood Flow Effects of Vitamin C | ||||
| Official Title ICMJE | Cognitive and Cerebral Blood Flow Effects of Vitamin C | ||||
| Brief Summary | This investigation is interested in the effects of high dose vitamin C on endothelial function in healthy humans. A high fat meal will be utilized to induce endothelial dysfunction. It is hypothesized that, via antioxidant actions, vitamin C will reverse these effects and in turn improve blood flow- the involvement of nitric oxide suggests that this could extend to cerebral blood flow. This will be monitored by trans cranial doppler flow meter and near infrared spectroscopy. |
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| Detailed Description | The acute effect of administering vitamins has received little research attention. The exceptions are a number of studies that have observed that single doses of a variety of vitamins, including Vitamin C, E and several B vitamins, ameliorate endothelial dysfunction in the periphery in participants who smoke, or suffer disorders such as diabetes mellitus and cardio-vascular disease. Endothelial function also varies in healthy people as a consequence of diet, and it is possible that antioxidant vitamins can attenuate the vaso-constriction associated with commonly consumed foodstuffs. Indeed, a study by Title et al (2000) showed that vitamin C improved endothelial function in the forearm following a glucose drink. Given the putative underlying mechanisms involved (e.g. nitric oxide synthesis) any improvement may well also extend to cerebral blood flow (CBF), and therefore improvements in aspects of cognitive function. The study will therefore assess the effects of a single dose of 1000 mg of vitamin C on cognitive performance and cerebral arterial blood flow velocity (cBFV) using Trans-cranial Doppler, following a high fat meal that has been used in previous endothelial function research. The high fat meal will be administered 2 hours before testing begins. Research shows that a meal of this type produces effects on the endothelium which are similar to those induced by dysfunctions such as diabetes i.e. blood flow restriction. No adverse effects have been reported with regards this methodology however. In order to monitor the effects of vitamin C (or not in the case of placebo) on endothelial function and cerebral blood flow near infrared spectroscopy (NIRS) and trans cranial Doppler (TCD) recordings will be taken throughout (in the case of the former technique) and at intermittent stages (in the case of the latter). Both neuroimaging modalities, when used correctly) are entirely safe. Blood pressure readings will also be taken intermittently throughout testing sessions. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: Vitamin C
Vitamin C will be administered at a dose of 1000mg. There will be at least a 48 hour wash out period between both conditions (placebo and vitamin C), with the order dicteted by Latin square. |
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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 | Completed | ||||
| Enrollment ICMJE | 24 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01055418 | ||||
| Other Study ID Numbers ICMJE | 24AD1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | David Kennedy, Northumbria University | ||||
| Study Sponsor ICMJE | Northumbria University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Northumbria University | ||||
| Verification Date | May 2013 | ||||
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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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