NCT01055418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

8 months

First QC Date

January 22, 2010

Last Update Submit

May 1, 2013

Conditions

Endothelial FunctionCognition

Keywords

Vitamin CCognitive performanceCerebral blood flowTrans cranial dopplerNear infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

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

    ~100 mins

Secondary Outcomes (1)

  • Cognitive performance

    ~50 mins

Study Arms (2)

placebo

PLACEBO COMPARATOR
Dietary Supplement: Vitamin C

Vitamin C

EXPERIMENTAL
Dietary Supplement: Vitamin C

Interventions

Vitamin CDIETARY_SUPPLEMENT

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.

Vitamin Cplacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male/Female,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain, Performance and Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • David Kennedy

    Northumbria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 25, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

GB(1)