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CompletedNCT01055418Updated May 3, 2013

Cognitive and Cerebral Blood Flow Effects of Vitamin C

A Phase 4 interventional study of Vitamin C in Endothelial Function and Cognition, sponsored by Northumbria University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-03.

Sponsored by Northumbria University · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endothelial Function
  • Cognition

Keywords

  • Vitamin C
  • Cognitive performance
  • Cerebral blood flow
  • Trans cranial doppler
  • Near infrared spectroscopy
03

In context

Lead sponsor

Northumbria University is the lead sponsor of 156 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male/Female,

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Placebo comparator
    placebo

    Dietary Supplement: Vitamin C

  • Experimental
    Vitamin C

    Dietary Supplement: Vitamin C

Interventions

  • Dietary supplementVitamin 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.

06

What researchers measure

Primary outcomes

  1. Endothelial function (using cerebral blood flow as a proxy measurement as measured by TCD and NIRS.

    Time frame: ~100 mins

Secondary outcomes

  1. Cognitive performance

    Time frame: ~50 mins

07

Study locations

1 site
  • Brain, Performance and Nutrition Research Centre, Northumbria University
    Newcastle upon Tyne, Tyne and Wear NE1 8ST, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01055418
Lead sponsor
Northumbria University
Responsible party
David Kennedy (Professor, Northumbria University) — Principal investigator
First posted
Jan 25, 2010
Start date
Jan 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
May 3, 2013

Study contacts

David Kennedy
study director · Northumbria University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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