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
Protocol serial number	N3RCT07
Sponsor	Institute of Child Health (UK)
Funders	Part of MRC Programme Grant, Kellogg's Sales & Marketing plc, Martek Biosciences plc

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

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	N3RCT
Study objectives	Primary: 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) studied	Cardiovascular disease
Intervention	Docosahexaenoic acid v Placebo
Intervention type	Other
Primary outcome measure(s)	Cardiovascular: Flow mediated endothelial dependent dilatation of the brachial artery, arterial distensibility and pulse wave velocity. Cognitive: CANTAB (CAmbridge Neuropsychological Test Automated Battery).
Key secondary outcome measure(s)	Cardiovascular: 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.
Completion date	31/05/2006

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Not Specified
Target sample size at registration	300
Key inclusion criteria	Healthy volunteers
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/11/2004
Date of final enrolment	31/05/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Child Health

London
WC1N 1EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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