The Influence of n-3 Fatty acid Supplementation on Vascular and Cognitive Function in Healthy Young Adults; a Randomized Controlled Trial

ISRCTN ISRCTN19987575
DOI https://doi.org/10.1186/ISRCTN19987575
Secondary identifying numbers N3RCT07
Submission date
27/01/2005
Registration date
05/05/2005
Last edited
03/07/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Atul Singhal
Scientific

Institute of Child Health
London
WC1N 1EH
United Kingdom

+44 (0)2079052389
a.singhal@ich.ucl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymN3RCT
Study objectivesPrimary:
Cardiovascular:
n-3 PUFA supplementation improves vascular function (flow-mediated endothelial dependent dilation) in healthy young adults.

Cognitive:
n-3 PUFA supplementation improves cognitive function in healthy young adults.

Secondary:
Cardiovascular:
n-3 PUFA supplementation improves other cardiovascular risk-factors in healthy young adults (vascular, biochemical and haematological).

Cognitive:
n-3 PUFA supplementation improves mood in healthy young adults.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular disease
InterventionDocosahexaenoic acid v Placebo
Intervention typeOther
Primary outcome measureCardiovascular:
Flow mediated endothelial dependent dilatation of the brachial artery, arterial distensibility and pulse wave velocity.

Cognitive:
CANTAB (CAmbridge Neuropsychological Test Automated Battery).
Secondary outcome measuresCardiovascular:
Plasma and red cell DHA and EPA levels and biochemical and haematolgical risk factors for CVD including such as fasting insulin, glucose, 32-33 split proinsulin, and leptin concentration and lipid profile including lipoprotein particle size will be determined. Hematological risk factors for CVD will include FBC, fibrinogen, factors VII and VIII, von Willebrand factor, soluble thrombomodulin and tissue plasminogen activator concentrations and inflammatory markers such as IL-6, IL-8 and CRP. Evidence of endothelial cell activation will be sought by the measurement of intra cellular adhesion molecule¿1 (ICAM-1), vascular cell adhesion molecule¿1 (VCAM-1), E-selectin, P-selectin IL-6 and other cell adhesion factors.

Cognitive:
Wechsler Abbreviated Scale of Intelligence (WASI; 29); inspection time, and a self-administered measure of mood (5 minutes) using visual analogue scales.
Overall study start date01/11/2004
Completion date31/05/2006

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexNot Specified
Target number of participants300
Key inclusion criteriaHealthy volunteers
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/2004
Date of final enrolment31/05/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Funders

Funder type

Not defined

Part of MRC Programme Grant

No information available

Kellogg's Sales & Marketing plc

No information available

Martek Biosciences plc

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/07/2013 Yes No
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