- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01055418
Cognitive and Cerebral Blood Flow Effects of Vitamin C
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Tyne and Wear
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Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 8ST
- Brain, Performance and Nutrition Research Centre, Northumbria University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male/Female,
- 18-35
Exclusion Criteria:
- Smokers,
- not proficient in English,
- are (or are seeking to become) pregnant, are currently taking illicit,
- over the counter/prescription medication (including the contraceptive pill),
- and/or dietary/herbal supplements.
- Food allergies or sensitivities that are relevant to the study,
- a history of/current head trauma,
- learning difficulties,
- ADHD and
- migraines.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
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.
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelial function (using cerebral blood flow as a proxy measurement as measured by TCD and NIRS.
Time Frame: ~100 mins
|
~100 mins
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cognitive performance
Time Frame: ~50 mins
|
~50 mins
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: David Kennedy, Northumbria University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24AD1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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