Condition category
Circulatory System
Date applied
27/01/2005
Date assigned
05/05/2005
Last edited
03/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Atul Singhal

ORCID ID

Contact details

Institute of Child Health
London
WC1N 1EH
United Kingdom
+44 (0)2079052389
a.singhal@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N3RCT07

Study information

Scientific title

Acronym

N3RCT

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular disease

Intervention

Docosahexaenoic acid v Placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cardiovascular:
Flow mediated endothelial dependent dilatation of the brachial artery, arterial distensibility and pulse wave velocity.

Cognitive:
CANTAB (CAmbridge Neuropsychological Test Automated Battery).

Secondary outcome measures

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.

Overall trial start date

01/11/2004

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers

Participant type

Healthy volunteer

Age group

Adult

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2004

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Institute of Child Health (UK)

Sponsor details

30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7242 9789
t.austin@ich.ucl.ac.uk

Sponsor type

Government

Website

http://www.ucl.ac.uk/ich/homepage

Funders

Funder type

Not defined

Funder name

Part of MRC Programme Grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Kellogg's Sales & Marketing plc

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Martek Biosciences plc

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Results in http://www.ncbi.nlm.nih.gov/pubmed/23817470

Publication citations

  1. Results

    Singhal A, Lanigan J, Storry C, Low S, Birbara T, Lucas A, Deanfield J, Docosahexaenoic acid supplementation, vascular function and risk factors for cardiovascular disease: a randomized controlled trial in young adults., J Am Heart Assoc, 2013, 2, 4, e000283, doi: 10.1161/JAHA.113.000283.

Additional files

Editorial Notes